Recalling Firm
Blood Systems, Inc. dba United Blood Services Texas
LifeSouth Community Blood Centers Inc - Birmingham Region
Lifesouth Community Blood Centers - Montgomery Region
So Ca Permamente Med Group Blood Donor Cntr
American National Red Cross Southeastern Michigan Region
DePuy Mitek, Inc., a Johnson & Johnson Co.
Stryker Instruments Div. of Stryker Corporation

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
Worldwide Distribution - USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and U.S. Virgin Islands; and countries of: Croatia, Dominican Republic, Turks and Caicos.
Worldwide Distribution - USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and U.S. Virgin Islands; and countries of: Costa Rica and Dominican Republic.
Pennsylvania; North Carolina; Wisconsin; Ohio; California; New Jersey; Minnesota; New York
Worldwide Distribution-USA (nationwide) and the country of Canada.
Nationwide Distribution including FL, TX, OK, MO, IL, OH, VA, OR, CO, KS, CT
Nationwide Distribution including MO, MA, NY, WI, OH, NY, CA, FL, NC, MN, and WA.
US Distribution including the states of AZ, KY, PA, IA WV, FL, MO, OK, CA, AR, MT, NY, KS, and CT.
Worldwide Distribution: USA Nationwide and the countries of: Egypt, India, Germany, Turkey, Canada, Saudi Arabia, Greece, United Kingdom, Cayman Islands, Kazakhstan, Republic of Korea, Taiwan, Hong Kong, China, Lebanon, Argentina, Denmark, Belgium, Netherlands, Mexico, France, Australia, Panama, Italy, Guam, United Arab Emirates, Israel, Polan, Venezuela, Austria, Hungary, Lithuania, Norway, Malaysia, Colombia, Costa Rica, Ecuador, Jamaica, Peru, Thailand, Italy, Czech Republic, Cameroon, South Africa, Portugal, Finland, Sweden, Nigeria, Bahamas, Cambodia, Dominican Republic, Switzerland, Chile, Singapore, Spain, Syrian Arab Republic, Jordan, Japan.
Worldwide Distribution-USA including Puerto Rico and Canada.
Worldwide Distribution - USA (Nationwide) and in the countries of: Australia , Austria , Belgium , Canada , Czech Republic , Denmark , Finland , France, Germany , India, Ireland , Israel, Italy , Latvia , Netherlands , Norway , Nepal, Poland , Portugal , Spain , Sweden , Switzerland , United Kingdom.
Worldwide distribution: US (Nationwide) including Puerto Rico and Virgin Islands; and countries of: Australia, Algeria, Belgium, Bolivia, Canada, Canary Islands, Chile, Croatia, Finland, France, Germany, Greece, Guatemala, Honduras, India, Israel, Italy, Japan, Jordan, Lima-Peru, Malaysia, Morocco, Nicaragua, Portugal, Saudi Arabia, Seoul Korea, Serbia, Singapore, South Africa, Spain, Switzerland, Turkey, Utd.Arab.Emir., United Kingdom, and Venezuela.
Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.
Worldwide Distribution - USA Nationwide in the states of: AR, AZ, CA, CO, CT, FL, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NM, NY, OH, OK, OR, PA, TN, UT, VA, WA and WV and the country Canada.
Worldwide distribution: US (nationwide) in the state of: TX and countries of: Colombia, Hong Kong and Korea.
Product distributed to Arizona, California, Colorado, Idaho, Nevada, Oregon, Utah, and Washington. Including Govt/military/VA.
Distribution was nationwide through retail and internet sales. The distribution list is pending.
Worldwide distribution: US (nationwide) including states of: TX, FL, IL, IA, ND, WI, VA, and NJ.; and countries of: CANADA, POLAND and SWITZERLAND.
US Distribution including the states of AL, AR, CA, CT, FL, GA, IA, IL, MS, NY, OH, SC, TN, and TX.
Worldwide Distribution - US including Michigan and the countries of Ireland and Australia
Worldwide Distribution: USA (Nationwide) and countries of: Canada and Mexico.
Nationwide in US and worldwide to: Australia, Canada, Malaysia, Taiwan, Italy
Worldwide distribution: US (Nationwide) including Puerto Rico; and countries of: Algeria, Aruba, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malta, Martinique, Mexico, Morocco, Netherlands, Netherlands Antilles, New Caledonia, Norway, Oman, Pakistan, Panama, Peru, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, and Venezuela
Nationwide in US and worldwide to Japan, Taiwan, Belgium, and Canada
Worldwide distribution: US (Nationwide)and in the country of Canada. (note: the ceiling supply units are not classified as a medical device by Health Canada).
Worldwide Distribution-USA (nationwide) and the countries of EMEA, APAC, Japan, Canada. AE, AU, BE, BH, CA, CH, CL, CN, CO, DE, EC, ES, GB, GR, HK, HU, IL, IN, IT, JP, KR, KW, MX, MY, NX, PA, PH, PK, PL, PR, QA, RU, SA, SG, SI, TH, VE, VN, ZA, and Tripoli.
Worldwide distribution: US (nationwide) including states of: AL, AZ, CA, CT,DE, FL,GA, HI, IL, IN, IA, KS, MD,MA, MI,MN, MS, O. NV, NH, NJ, NY, NC, OH, OK, OR, PA, SD, TN, TX , UT, VA, WA, WI. OUS: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BYELO RUSSIAN, CANADA, CHINA, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONDURAS, HON KONG, HUNGARY, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, KUWAIT, LATVIA, LIBYA, LITHUANIA, LUXEMBOURG, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, and UNITED KINGDOM. .
US and Australia, Azerbaijan, Brazil, Canada, Germany, Great Britain, Hong Kong, Ireland (Eire, Japan, Malaysia, Malta, Mexico, New Zealand, Panama, Philippines, Russia, South Korea, Spain, Switzerland, Thailand.
Nationwide in US and worldwide to Canada, United Kingdom
Distributed to ID, MN, and SC. Foreign distribution to Sweden. No military/govt/VA consignees.
Worldwide Distribution - USA (nationwide) and country: Canada.
Nationwide Distribution including the states of KY, OH, TX, MA, and NC.
US: Nationwide (AL, FL, GA, IL, IN, KS, KY, MI, MO, MS, NC, OH, SC, TN, WI)
Nationwide Distribution-including the states of AZ, CA, FL, GA, IL, KY, MA, MN, NC, NJ, NV, NY, OH, OR, TN, TX, and UT.
US Distribution in the states of: California, Colorado, Delaware, Florida, Maryland, Missouri, New Jersey, New York, Ohio, Pennsylvania, Tennessee, and Virginia
Worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Lebanon, Malaysia, Mexico, New Zealand, Netherlands, Norway, Peru, Poland, Portugal, Saudi Arabia, Singapore, Spain, South Africa, Sweden, Switzerland, United Arab Emirates, and United Kingdom.
Worldwide Distribution-USA including DC and the states of MO,TX,OK, LA, MA, CA, WI, and MI and the country of Canada.
US only - CA, TX, FL, MS, WA, NC, MA, IN, NC, NY, PA.
Worldwide Distribution - USA (nationwide) United States and Internationally to Austria, Belgium, Brazil, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Ireland, Italy, Japan, Latvia, Lithuania, Luxembourg, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Romania, Russia, South Africa, Spain, Sweden, Switzerland, Turkey, and the United Kingdom.
USA Nationwide Distribution in the states of: CA, FL, GA, IA, NV, NY, LA, IN, PA, OR, TX, and WI.
Worldwide Distribution-Distributed in Puerto Rico and the countries of France, Indonesia, Korea, Nicaragua, Philippines, and Taiwan.
US and Australia, Guatemala, United Kingdom, Israel, Canada and Japan.
MD for further distribution by own label distributor
US States: FL, OH, MN, WA, CA, UT, SC, TN, IA.

Product Description
Plum A+ Hyperbaric Infusion Pump; List Number 11005; Labeled in part: PLUM A+ HYPERBARIC; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
Plum A+ Infusion Pump; List Number: 11971; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
Plum A+ Infusion Pump; List Number: 11973; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
Plum A+3 Infusion Pump System; List Number: 12348; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
Plum A+ Infusion Pump; List Number: 12391; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
Plum A+ Infusion Pump; List Number: 12618; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
*** 1) Plum A+ Infusion Pump; List Number: 20678; Labeled in part: PLUM A+3; for use with Hospira MedNet; *** 2) Plum A+ Infusion Pump; List Number: 20679; Labeled in part: PLUM A+; for use with Hospira MedNet; *** 3) Plum A+ Infusion Pump with Hospira MedNet Software; List Number: 20792; Labeled in part: PLUM A+; for use with Hospira MedNet; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
The Plum A+ Hyperbaric Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Hyperbaric Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+ Hyperbaric Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual. The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.
The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+ Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual. The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.
The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+3 Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+3 Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual. The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.
Platelets Pooled Leukocytes Reduced Irradiated
Blood and Blood Products for Reprocessing
Platelets Pheresis Leukocytes Reduced Irradiated
PRIESTER'S PECANS brand brand ROASTED SALTED PISTACHIOS, item #18010, Net Wt. 1 lb (454g), UPC 720056180104; item #15502, Net Wt. 8 oz (226.8g), UPC 001001155027; Stock No. 189, Net Wt. 2 lb (907g)
PRIESTER'S PECANS brand NUTTY FAVORITES ASST, Stock No. 79, Net Wt 1 lb 10 oz (737g)
PRIESTER'S PECANS brand FANCY ROASTED NUTS, Stock No. 7, Net Wt 12 oz (454g)
Red Blood Cells Leukocytes Reduced Irradiated
Red Blood Cells (Apheresis) Leukocytes Reduced
2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number: 03-2962-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
Combiset Blood Line with BVM for Hemodialysis use Catalog Number: 03-2965-9. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
Combiset Blood Line Hemodialysis use Catalog Number: 03-2622-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which have four protrusions used for ratcheting. They come in straight and pointed varieties, either with or without a tab containing an additional bend. Extension shims are designed to slide down retractor blades, and are optional retractor components utilized during lumbar interbody fusion procedures. They are intended to manipulate tissue and prevent tissue from interfering inside the surgical field.
Siemens syngo.plaza image processing system image processing radiological system
Artis zee systems x-ray, angiographic system
Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the Pneumatic Motor Systems including: BlackMax Motor Systems, MicroMax Systems and XMax Motor Systems all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone.
Cutting Bur Chart (part number 20-0019) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone
Product Catalog (part number 20-0020) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone.
US Pistachio Shelled, Halves, Raw, Net Weight: 30lbs.
SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.
DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 Product Usage: The Intermediary Tubing for FMS Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing integrates several functional components including: luer locks for attaching the tube to the Inflow tubing and sheath, clamps, and a one-way valve. The FMS Intermediary Tubing is sterile and intended for single use with the FMS Fluid Management Systems in a surgical setting by personnel trained in arthroscopy .
DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649 Product Usage: The Intermediary Tubing for FMS Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing integrates several functional components including: luer locks for attaching the tube to the Inflow tubing and sheath, clamps, and a one-way valve. The FMS Outflow Tubing with One-Way valve is sterile and intended for single use with the FMS Fluid Management Systems in a surgical setting by personnel trained in arthroscopy.
VerSys Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage Hip System Revision Femoral Stems. Indicated for total hip arthroplasty.
GoPicnic Black Bean Dip & Plantain Chips; ready-to-eat meal kit with professor zim zam's extraordinary sweets dark chocolate with orange packaged in paperboard container; NET WT 4.2 OZ (116.2g); distributed by gopicnic brands, inc.; chicago, il 60613; www.gopicnic.com;
Gopicnic; Hummus & crackers; GoPicnic meal kit packaged in paperboard container. ready-to-eat meal; with professor zim zam's extraordinary sweets dark chocolate with sea salt. NET WT 4.1 OZ (116g); distributed by gopicnic brands, inc.; chicago, il 60613; www.gopicnic.com
Carestream Vue PACS; VIRTUAL ACCESS SOFTWARE, WORKGROUP The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; Virtual Access Plus SW, Workgroup The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; Virtual PWR Reading Basic SW, Workgroup The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; Virtual PWR Reading Basic SW, 8 Pack The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; Virtual PWR Reading Basic SW Workgroup The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; Virtual PWR Reading Basic SW 8 Pack The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; Virtual Access Software, StandAlone The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; Virtual Access Pluse SW, StandAlone The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; Virtual Enterprise SW StandAlone The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; Virtual PWR Reading Basic SW StandAlone The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; Virtual Reading Basic SW StandAlone The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; Unlimited Reading LIC<7.5K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; Unlimited Reading LIC<15K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<7.5K EX/Y The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<15K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; UNLIMITED READING LIC < 25K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; UNLIMITED READING LIC < 50K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; UNLIMITED READING LIC ADD 10K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; UNLIMITED READING LIC ADD 25K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; UNLIMITED READING LIC ADD 100K E/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; MX-O SA WORKSTATION SW LICENSE The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; MX CLINIC SOFTWARE DICOM VIEWING The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; MX RAD SW ADV CR/DR LAYOUT & VIEW The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; MX PRINT SW AUTO LAYOUT PAGE & PRINT The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC< 7.5K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 15K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 25K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 50K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 75K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; UPG MX-O SVR 7.5K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; UPG MX-O SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; UPG MX-O SVR 75K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; MX WEB SW/ 1 MX-O CONCUR ACCESS LIC The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<75K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<50K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<25K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; MX WEB SW/1 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; MX WEB SW/5 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; MX WEB SW/10 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; MX WEB SW/15 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; MX WEB SW/25 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; UPG MX-RAD SVR 7.5K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; UPG MX-RAD SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; UPG MX-RAD SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; UPG MX-RAD SVR 50K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Carestream Vue PACS; UPG MX-RAD SVR 75K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B) Product Usage: Intended to be used as a visual aid during the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy.
Access 2 Immunoassay System, Part Number: 81600N The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
Dannon LIGHT & FIT Nonfat Yogurt - 4 PACK of 6 oz cups. Vanilla UPC 36632 02721
Dannon LIGHT & FIT Nonfat Yogurt - 4 PACK of 6 oz cups. Peach UPC 36632 02722.
Dannon LIGHT & FIT Nonfat Yogurt - 4 PACK of 6 oz cups. Strawberry UPC 36632 02720.
Dannon LIGHT & FIT Nonfat Yogurt - 4 PACK of 6 oz cups. Strawberry/Banana UPC 36632 02181.
Dannon LIGHT & FIT Nonfat Yogurt - 4 PACK of 6 oz cups. Cherry UPC 36632 02180.
Dannon LIGHT & FIT Nonfat Yogurt - 4 PACK of 6 oz cups. Blueberry UPC 36632 02723.
Apotheca Energique Gastrozyme, dietary supplement, 100 vegetarian capsules.
Acetabular Pressurizer; single use and six units per box. The Acetabular Pressurizer 0206-522-000 is an accessory to the Advanced Cement Mixer (ACM). The Acetabular Pressurizer Tiplet P/N 0206-522-012 is sealed in a two pouches, sterilized, and labeled as part number 0206-522-000. This Acetabular Pressurizer is an accessory used to pressurize the cement applied to the prosthesis to be implanted during the surgery. The Acetabular Pressurizer is an injection molded component made with resin material DOW HDPD 10462N which is a rigid plastic once it is molded.
Composite Series Skull Clamp, one clamp per tote. The MAYFIELD Skull Clamp (A3059) is a cranial stabilization device, designed to provide rigid skeletal fixation. The Skull Clamp is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary
3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur Plating System combines implants and instruments in one convenient system. This system offers the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates provide ease of reduction and good rotational stability while maintaining bone stock. Cannulated instruments work over a guide wire for precise placement and safety. The subject device is a Bone Screw designed for use with this system.
Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, bmT, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.
Cellulase: ACTA 4-702 APEX 17-6262 APEX 6-9762 ARTH EB 10831 BETA GLUCANASE 1000 BROOK 8-352 CELLULASE 1000 CELLULASE 4000 CELLULASE CONC. CENTURY 7-152 CLENZSEB DIGESEB DIGESEB PB DIGESEB PLUS DIGESEB PLUS 401 DIGESEB SUPER DIGESEB SUPER 118 EB 10-14081 EB 10-15351 EB 12-706 EB 14-14201 EB 16-15612 EB 17-14161 EB 5-13302 EB 5-14121 EB 5-15361 EB 8-15731 EB 9-14181 EB 9-14191 EL 5-7212 GLOBAL 8-658 GREENZYME 427 HEMISEB JARL 3-164 NAT 9-185 NF 525 NHK 14-9451 NPC 270 NPC 5005 NPC 6006 NW 7B 9142 PB 10401 SEB GLUTEN RELIEF SEB GLUTEN RELIEF HNS SUPER 108 TUMMYEASE VEGPANZYME PLUS VR 5-8451
Protease: APEX 10-7082 CENTURY 7-152 EB 2-14511 EB 5-16901 EB 8-14861 EB 9-14191 EXCLZYME EXCLZYME EN GLOBAL 8-658 HFN 7-7113 META 10-185 MHNHEM 2-158 PEPZYME AG PROTEASE - 1000 PROTEASE 250,000 SEB PRO FP 500 SEB PRO FP 600 SYS 7-7742 UT 11-216 N VEGPANZYME 1213 VEGPANZYME PLUS
Cellulase & Protease: APEX 10-639 A DIGESEB DIGESEB PLUS DIGESEB SUPER EB 10-14171 EB 10-16192 EB 12-11331 EB 12-9205 EB 14-14201 EB 15-13662 EB 18-13081 EB 7-12831 EB 7-12901 EB 7-14211 EB 8-15731 EL 5-7212 ENZIGEST N FIZYME # 1209 N GLOBAL 8-658 HERB 10-6973 HFI 4-7601 HFN 7-7113 META 10-185 NB 6-7812 NF 525 NHK 14-9451 NPC 7007 NPC 8008 NUTRO 8-7961 OHS - 9804 PROTHERA 18-9724 PROTHERA 19-9723 PROTHERA 8-12182 SD 7-581 SEB GLUTEN RELIEF SEB GLUTEN RELIEF HNS UT 11-216 N VEGPANZYME 1213 VEGPANZYME 1X VEGPANZYME PLUS VT 11-693
Papain: NF 4-608 B NF 4-6152 NUTRA 6-452 PAPAIN PROHYDROXY NF 4-714
Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation.
Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, models 37602 and 37603. Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation.
WELLTRIENTS DIGESTAIDS FORMULA #2, 90 capsules per bottle. Item #61256-90
Spectrazyme, 180 count, 60 count, 12 bottles/case, 20000 tablets/box, 14000 capsules/pail.
Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating theaters and intensive care
Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture sensitive reusable medical devices.
AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.): AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION): AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis for diagnosis, except in the case of mammography images. K110834: AW VolumeShare 5 is a review workstation, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis of diagnosis, except in the case of mammography images. K081985: AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications.
Serralase Enzyme Supplements; Packaged in 90 and 180 tablet bottled UPC - 90 count: 8 28054 00542 6 UPC- 180 count 8 28054 00149 7; Manufactured by: ProThera, Inc., Reno, NV 89521
Klaire Labs Vital-Zymes Chewable; Comprehensive Enzyme Supplement; 180 Chewable tablets. UPC 7 09616 0218 5 Manufactured by ProThera, Inc., , Klaire Labs is a division of ProThera Reno, NV 89521
Klaire Labs Vital-Zymes complete; Comprehensive Enzyme Supplement; 120 Vegetarian tablets. UPC 790616310005 Manufactured by ProThera, Inc., , Klaire Labs is a division of ProThera Reno, NV 89521
Klaire Labs Interfase; Enzyme Supplement; Packaged in 60 and 120 Vegetarian capsules bottles. UPC 60 ct.- 7 0961 012270 7; UPc 120 ct. - 7 09616-01229 1 Manufactured by ProThera, Inc., , Klaire Labs is a division of ProThera Reno, NV 89521
Klaire Labs Interfase Plus; Enzyme Supplement; 120 Vegetarian capsules bottles. UPC 7 09616 01228 4 Manufactured by ProThera, Inc., , Klaire Labs is a division of ProThera Reno, NV 89521 Notation: Product #6 Clean Cut Enzyme wasn't entered into RES because the product never left the warehouse.
GlutenFlam (K-52) Enzyme & Bioflavonoid Dietary Supplement, 60 vegetarian capsules
SuperDigestZyme (Z22), Plant Enzyme and Cofactor Dietary Supplement, 100 tablets
LGS-Zyme (Z12), Enzyme-Based Multivitamin & Amino Acid Dietary Supplement, 120 Capsules
RepairVite (K63), Enzyme-Based Herbal & Amino Acid Dietary Supplement Powder, Caramel Flavor, Net Wt. 0.34 lb (155g)
All-Natural Greens Dietary Supplement; Manufactured Exclusively for NatureRich, Maple Grove, MN 55369.
Natural Balanced Nutrition Vanilla Energy Shake Dietary Supplement; Manufactured for NatureRich, Maple Grove, MN.
Vive Shake Up Your Health Chocolate; Made for and distributed by renewal wellness.
Empirical Labs Building Health SuperFuel Plus Mocha Flavor; Whey protein isolate (milk); Dietary Supplement
Empirical Labs Building Health SuperFuel Tropical Dietary Supplement
Dynamite Specialty Products Tri-Mins Daily Foundation, calcium, magnesium, potassium dietary supplement; 240 Capsules; Manufactured for Dynamite Marketing, Inc, Meridian, ID 83642.
Empirical Labs Building Health Superfuel; 240 Capsules Dietary Supplement
Empirical Labs Building Health Inte-Zyme; 180 Capsules Dietary Supplement
Empirical Labs Building Health Thyroid; 90 Capsules Dietary Supplement
Empirical Labs Building Health Vascuzyme; 90 Capsules Dietary Supplement
Empirical Labs Building Health P&L Enzymes; 180 Capsules Dietary Supplement
Non-GMO Ingredients Go Green Fuel for the Entire Body Dietary Supplement. All-Natural Greens Dietary Supplement. Manufactured Exclusiveley for: Hsin Ten Enterprise USA, Inc. Industry, CA 91748.
Empirical Labs Building Health Digesti-Zyme; 180 Capsules Dietary SupplementSupplement
Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare Informatics, Inc. Foster City, CA IntelliSpace PACS are image management systems intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RE, RT, MG, SC, VL, as well as hospital/radiology information systems.
Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx only, Sterile EO. Intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical atrial flutter.
Beachbody Optimize Enzymes Capusles, 126 CT, 8 oz. Container size: JAR 8OZ WHITE 70MM NECK POLYPROPYLENE 126 capsules per bottle. Product labeling reads in part:'' BEACHBODY ULTIMATE OPTIMIZE Promotes healthy metabolism and effective body funtions***DIETARY SUPPLEMENT 126 Capsules***BEACHBODY, LLC Santa Monica, CA***''.
Beach Body Ultimate Reset Kit 2.0( each Kit consist of 1 bottle of the above optimize enzymes capsules product and 5 bottles of additional product) Product labeling reads in part:'' BEACHBODY ULTIMATE RESET KIT 2.0*** BEACHBODY, LLC Santa Monica, CA***''.
*** 1) Corn meal mix packaged in a paper bag labeled in part: Aunt Jemima; Buttermilk; Self-Rising White; Corn Meal Mix; Flour, Salt & Baking Powder Already Blended In; NET WT 32 OZ (2 LB); *** 2) Corn meal mix packaged in a paper bag labeled in part: Aunt Jemima; Buttermilk; Self-Rising White; Corn Meal Mix; Flour, Salt & Baking Powder Already Blended In; NET WT 5 LB
White grits packaged in a paper bag labeled in part: Smooth & Creamy; Aunt Jemima; Quick GRITS; Cooks in about 5 minutes; ENRICHED WHITE HOMINY; NET WT 36.8 oz. (2 lb. 4.8 oz.) 1043g
Prostiva RF Therapy Hand Piece Kit, REF 8929, Rx only, sterilized using Ethylene Oxide. The Prostiva RF Model 8929 Hand Piece Kit is the delivery system component of the Prostiva RF Therapy System. Prostiva RF Therapy delivers low-levels of radiofrequency (RF) energy directly into the hyperplastic tissue for the treatment of benign prostatic hyperplasia (BPH). The RF energy delivered by the system provides selective thermal ablation of prostate tissue to help reduce urethral constriction and relieve BPH voiding symptoms. The Prostiva RF Therapy System consists of the following major components: '' Radio Frequency Generator '' Hand Piece Kit '' Telescope The Model 8929 Prostiva RF Therapy Hand Piece Kit contains the following single-use, disposable components: '' One sterile Hand Piece with radio frequency cable (Model 8929) '' One sterile Tubing System (Model 6101) '' One non-sterile Return Electrode (Model 8934) The hand piece has two insulated electrode needles that deliver the radio frequency energy interstitially to the prostate. These needles are covered by insulating shields that localize the lesions within the prostate, protect the urethra from thermal damage, and eliminate collateral thermal damage. The Hand Piece stainless steel (SS) tube is inserted into the urethral canal up to the prostate with the aid of a telescope for visualization during the therapy. The Hand Piece features two insulated Nitinol needles inside the SS tube. The needles can be deployed (extended), at approximately a 90-degree angle from the SS tube, to a preset depth of between 12 mm and 22 mm (at 2 mm intervals). The needles inside the SS tube are deployed into, or retracted from the prostate, using the handle lever. RF energy is delivered through the needles to the prostate tissue. The RF energy creates molecular friction eventually resulting in tissue heating and cell death (therapy intent).
Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, MADE IN GUATEMALA cleaning of fluids from surgical site in or near the eye
Applied Medical's Inzii 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.
Sarns'' Soft-Flow Aortic Cannula without Suture Flange, angled tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD with 3/8'' connector, 14'' (36 cm) long. Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Sarns'' Soft-Flow Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 7.0 mm (21 Fr) OD with 3/8'' connector, 14'' (36 cm) long. Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Sarns'' Soft-Flow Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD with 3/8'' connector, 14'' (36 cm) long. Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Sarns'' Venous Return Cannulae, 20 Fr with 1/4'' flare, 14.5'' (37 cm) long. Indicated for venous drainage during cardiopulmonary bypass surgery for dial cannulation of the superior and inferior vena cava.
Fruit Truffles - Cherry, Coconut, Key Lime, Lemon, Mango, Pear, Pineapple and Tangelo flavors. (6 piece count/4.5 oz) Pear, Lemon, Key Lime, Coconut flavors contain FD&C Y5 and/or Y6; (9 piece count/7 oz) Pear, Cherry, Tangelo, Coconut, Lemon, Key Lime flavors contain FD&C Y5 and/or Y6 ; (12 piece count/9 oz) Mango, Pineapple, Tangelo, Cherry, Pear, Coconut, Key Lime, Lemon flavors contain FD&C Y5 and/or Y6; Firm also sells 2 piece count/1.5 oz products. However, this product only contains 2 strawberry flavors and do not contain FD&C Y5 and/or Y6. Sold to the hospitality industry. Product of the USA. Manufactured by Torn Ranch, Petaluma, CA 94954
Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In dentistry for dental surgery, endodontics and implantology.
Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened with xylitol and sorbitol, GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108. Biotene Mouth Spray is used for the treatment of dry mouth
Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system.
Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.
Bairn Biologics Candisol; Natural Enzymes to Support a Health Gastrointestinal Tract. Dietary Supplement; Ingredients: Vegetarian Cellulase, Vegetarian Hemicellulase, Vegetarian Xylanase, Vegetarian Beta-glucanase, microcrystalline Cellulose, L-Leucine, Vegetable Capsule. Packaged in 40 and 120 count amber glass bottles. Bairn Biologics, P.O. Box 95966 Las Vegas, NV 89183
Walnut shaped soft Cookie packed on styrofoam tray with plastic over wrap ASSI brand Korean Cake 20644D Net Wt.: 8 oz. Distributed by Rhee Bros., Inc. 7461 Coca Cola Dr Hanover, MD 21076 Expiration date 3/20/14 With Korean language labeling
Doughnuts packed on styrofoam tray with plastic over wrap ASSI brand Korean Cake 20645D Net Wt.: 8 oz. Distributed by Rhee Bros., Inc. 7461 Coca Cola Dr Hanover, MD 21076 Expiration date 1/29/14 With Korean language labeling
Sweet Bread known as Bam Bbang (Chestnut Bread) packed on styrofoam tray with plastic over wrap ASSI brand Korean Cake 20646D Net Wt.: 8 oz. Distributed by Rhee Bros., Inc. 7461 Coca Cola Dr Hanover, MD 21076 Expiration date 1/29/14 With Korean language labeling
Digestive Enzymes, 60 Capsules/Bottle under the following brand names: 21st Century Digestive Enzymes, 60 Capsules/Bottle. HyVee Digestive Eymes, 60 Capsules/Bottle.

Code Info
Excessive data in the Code Information for this product has caused issues with the CSV download function. The complete list of Code Information can be found at the <a href=''http://www.fda.gov/Safety/Recalls/EnforcementReports/UCM376115'' target=''_blank''>Addendum to Enforcement Report</a>.
model numbers 10094135, 10094137, and 10094141 equipped with a card collimator from a specific lot
Lot#TO010092, expiry date: September 2014
Product Code: 35700BAX, 35700ABB Serial Numbers: All
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1975903
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1013226
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1308519
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1530633
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1467067
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1405794
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1301761
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1337195
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8171837
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8230633
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1097229
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8380354
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8648503
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1673334
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8656456
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1149418
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1560713
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8976268
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1645324
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8768178
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8978504
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1384700
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8891640
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8678468
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8101768
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1630185
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1961382
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1549377
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 848164
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8215956
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8485021
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8711459
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8859811
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 886578
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1482116
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8274888
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8062374
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8446361
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1849592
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8203101
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8795866
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1387042
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1618198
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1738905
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1981042
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8296642
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8441602
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8553331
Lot number C3354 The product mathmatical analysis of potential Chloramphenicol level is 1.07 ppb.
Part Number:. 00-0903-2634 and lot number 009U2
Part No. 352.085 with lot numbers 20141 through 24510, and 4399543 through 5870257
Catalog Number A700238, Batch Number 4113243, 4152911. Catalog Number A700240, Batch Number 4113242, 4124985.
*** 1) Aunt Jemima; Buttermilk Self-Rising White Corn Meal Mix NET WT 32 OZ (2 LB); UPC: 30000 05468, 300000 54604; Best Before Date: March 4, 2014; Cases of 12 bags labeled with UPC: 10030000054502; *** 2) Aunt Jemima; Buttermilk Self-Rising White Corn Meal Mix NET WT 5 LB; UPC: 30000 05450, 300000 54505; Best Before Date: February 3, 2014; Cases of 8 bags labeled with UPC: 00300000546004
Aunt Jemima Quick Grits Enriched White Hominy: UPC:30000 04260, 300000 42601; Best Before Date: February 26, 2014
Kit Lot Number: 215251, Hand Piece Lot Number: 13E005M.
(6 piece count/4.5 oz) = ITEM CODE S307-H (9 piece count/7 oz) = ITEM CODE S308-H (12 piece count/9 oz) = ITEM CODE S309-H Lot numbers: 1453-2963 Best By Date: October 24, 2013-February 23, 2014 (Best by date is 4 months after manufacturing date of product)
all lots manufactured from 2009 forward; Expiry dates: March 2011 through May 2015.
product code: 20644D Expiration date: 3/20/14
product code: 20645D Expiration date: 1/29/14
product code: 20646D Expiration date: 1/21/14

Product Quantity
1) List Number 20679: 7,737 units; 2) List Number 20792:
89 units total (1 in US and 88 International)
8232 bottles of 40 count; 27, 882 bottles of 120 count.

Reason for Recall
Blood product, collected from a donor who tested reactive for the antibody to hepatitis B core antigen on two separate occasions, was distributed.
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180, E181/N181, E186/N186, E187/N187 or E346. Additionally, if the pressure sensor calibration has drifted, users may experience false distal occlusion alarms or distal occlusions that may not be detected. These errors invoke visual and audible warnings to the user. Hospira has identified the following design attributes of the pressure sensor that may cause the calibration to drift sooner than expected: strain gage protective layers' moisture resistance issues, pressure assembly chassis residual structural stress issues, and relaxation of clamping force from mounting screws for strain gage and pin stack.
Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspection of the distal pressure pin. A broken distal pressure pin could result in incorrect distal pressure readings, undetected distal occlusions and/or undetected cassette failures.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Blood products, held in quarantine pending results of an investigation, were distributed.
Blood product, manufactured from an apheresis unit with insufficient platelet yield for the unit to be split, was distributed.
Donor Screening/Deferral screening not done or incorrectly performed, including incorrect ID used during search, prior deferral due to history.
Blood products, collected from a donor who had been temporarily deferred, were distributed.
Blood product, collected from a donor considered to be at increased risk for Creutzfeldt-Jakob Disease (CJD), was distributed.
Pistachios, which were supplied by ARO and subsequently recalled, have the potential to be contaminated with Salmonella.
Blood products, exposed to unacceptable shipping temperatures, were distributed.
Blood products, collected from donors who were at risk for Leishmaniasis, were distributed.
Blood product, labeled with the incorrect platelet count and product volume, was distributed.
Blood product, with no documentation of monthly QC testing for pH, was distributed.
Blood products, which did not meet QC specifications for platelet pH, were distributed.
Blood products, with platelet counts below the specified minimum requirement, were distributed.
Blood product, with platelet count below the specified minimum requirement, was distributed.
Blood products, with disparate weights between the two units collected during the apheresis procedure, were distributed.
Blood product, not appropriately labeled as a low volume unit, was distributed.
Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss
Blood products, labeled leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.
Fit variation among all lots of S-LIFT extension shims with corresponding retractor blades. The firm's investigation revealed that extension shims may not fit down all retractor blades.
The firm became aware of an unintended behavior when using the syngo.plaza. The ''Rename'' functionality can cause an unintended patient merge if the patient is sent to another system. This issue affects customers who transfer patient data between two or more syngo.plaza or syngo Imaging XS systems.
The firm became aware of a potential issue with Artis zee systems bearing model numbers 10094135, 10094137, and 10094141 equipped with a card collimator from a specific lot where a dislocation of the scatter radiation filter inside the card collimator may occur.
Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling for its Pneumatic Systems Operating Manual, Cutting Burr Chart and Product Catalog due to a recent review of their regulations and compliance requirements that determined the claim that the device is capable of dissection of biometals, bioplastics and cement has been verified, but is is not part of the currently cleared indications for use fo the device(s). The currently cleared indications for use for the pnuematic and electric motor systems is ''cutting and shaping bone''.
Primex International Trading Corp. is recalling Pistachios Shelled, Halves, because it has the potential to be contaminated with Salmonella.
Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Human cornea, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed.
Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion Pump with Master Drug Drug Library due to reports of upstream occlusion alarms and air-in-line alarms occurring during infusions.
Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not perform as intended. may result in backflow of irrigation fluid into the One Day Set which may potentially lead to patient cross-contamination
Based on a review of historic packaging validations, it was determined that a subset of product packaged in one of the clean rooms at a single Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. The number of samples required for packaging testing (seal integrity and seal strength) to provide a 90% confidence and 99% reliability were not available for testing. As a result, Zimmer is recalling all lots of the product due to the potential that the sterile barrier integrity may be compromised.
The chocolates included in the meal kits may contain undeclared milk allergens.
Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Baxter Healthcare Corporation is recalling the LCD display screen on the SIGMA SPECTRUM Infusion Pump with Master Drug Library for not meeting standards for withstanding an electrostatic discharge.
Beckman Coulter is recalling the Access 2 Immunoassay System because they determined that the fuses in the system may be of the wrong amperage.
Dannon Company, Inc. is recalling Light n Fit Nonfat Yogurt because they may contain yeast.
Dannon Company, Inc. is recallingLight n Fit Nonfat Yogurt because they may contain yeast.
The products may contain chloramphenicol.
On March 14, 2013 a Work Order was opened for 120 units (20 boxes) of the Acetabular Pressurizer (P/N 0206-522-000 Rev. H). On March 15, 2013, when the product was going to be placed in the pouch to be sealed, the manufacturing operator noticed that some assemblies were cracked. As a result of the injection pressure of the cement gun, a cracked tiplet may release from the Hub during cement application. There is also the potential for cement to leak out from the fissure in the tiplet during setting time, resulting in an inadequate supply of cement required to complete the surgery.
An investigation of an adverse trend of complaints for the Skull Clamp index locking knob not easily unlocking or disengaging and malfunctions of the 80 lbs. torque knob was initiated. None of the complaints resulted in a report of patient injury, adverse health consequence, or a delay / prolongation of the surgical procedure.
The firm identified, through complaints that the 3.5MM LOCKING SCREW packaging material was marked as a 3.5mm screw and the part number was correct but that the description indicated a 7.0mm screw. Upon investigation, it has been determined that a lot number 009U2 was packaged and mislabeled internally by OrthoPediatrics.
Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of non-implant grade material.
Specialty Enzymes and Biotechnologies is recalling cellulase/mannanase and fungal protease because they may contain low levels of chloramphenicol.
Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulators under the following specific conditions: Switching between groups with Multiple programs or creating program groups. Therapy can be restored with the Physician Recharge mode (RPM) of the Implantable Neurostimulator Recharger (INSR).
Creation's Garden Natural Products (CGNP) is recalling Welltrients Digestaids Formula #2 because it has been found to contain chloramphenicol.
Ultra Laboratories is recalling Digestive Health because a raw material used in its formulation may have been contaminated with chloramphenicol.
Metagenics is recalling Spectrazyme because their raw material supplier informed them that enzymes in the blend may contain the antibiotic chloramphenicol.
Cases were encountered with the Draeger Movita 603x/DVE 803x Ceiling Supply Units where the drive screw in the motor unit broke and the lift arm fell down approximately 60 cm (23.6 inches).
Advanced Sterilization Products (ASP) is recalling the Sterrad 100NX Sterilizer some healthcare workers detected odors/smells emanating from the 100NX Sterilizers, and it may be related to normal breakdown of the oil used in the Sterrad 200 vacuum pumps.
GE Healthcare has recently become aware of a potential safety issue due to the image orientation within GSI viewer on AW products. The GSI Viewer application running on AW/Volume Share or on the AW Server when making a batch and rotating the batch group clockwise 180 degrees (Inferior to Superior) will display images in the Superior orientation. The orientation annotation on the image is correct. The concern is that the patient right/left representation is from the Superior view, which could result in a misreading of the image and misdiagnosis.
ProThera was notified by enzymes provided by Specialty Enzymes within the last 3-6 months may be contaminated with chloramphenicol.
Apex Energetics is recalling GlutenFlam, SuperDigestZyme, LGS-Zyme, and RepairVite because they may contain trace amounts of the antibiotic chloramphenicol. The dietary supplements on recall contain enzymes that are on recall by Specialty Enzymes Biotechnology, a raw material supplier, because it contains chloramphenicol.
Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol.
Philips Healthcare became aware of a software problem with the IntelliSpace PACS system, in that a timing issue has been identified that may result in a condition where the device does not store additional images received before processing is complete. The missing images may contain pathology which may result in a different diagnosis if they had been available at time of interpretation.
St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification regarding selected batched of Safire Duo Ablation Catheter MediGuide Enabled. These units have a cable connector configuration that is different than intended.
CGNP initiated this recall because the raw material Exclezyme received from Specialty Enzymes used by CGNP in the formulation of Beachbody Optimize Enzymes Capsules CG has been found to contain chloramphenicol.
Some Aunt Jemima brand Buttermilk Self-Rising Corn Meal Mix, Quick Grits Enriched with White Hominy, and Buttermilk Self-Rising Corn Meal Mix White have levels of aflatoxin above the legal limit..
Urologix is voluntarily recalling Prostiva RF Therapy Hand Piece Kits, Part Number 8929, Lot Number 215251 due to a Hand Piece not meeting an in-process force test specification.
Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees.
One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable product.
Applied Medical is conducting a voluntary recall of the Inzii 12/15mm retrieval system. During shipment, the retrieval system packaging has the potential to become punctured with small holes, which could compromise the sterile barrier. The likelihood of this situation to occur and result in patient harm is highly unlikely; however, out of an abundance of caution for patient safety and a commitment to provide only the highest quality products, Applied has decided to recall all potentially affected units.
During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns'' Soft-Flow Aortic Cannulae and Sarns'' Venous Return Cannulae.
FDA inspection at the firm found that Yellow # 5 and 6 used in decoration on top of fruit truffles was not declared in the ingredient statement.
The recall was initiated because there is a potential for malfunction of the OsseoCare Pro when used with the OseeoCare Pro iPad application software release 1.2.0.7.
Label indicates, ''Sweetened with xylitol and Sorbitol'', however product does not contain sorbitol.
Toshiba America Medical Systems, Inc. is recalling due to a potential problem with Specific Absorption Rate (SAR) values when using the Toshiba Titan 3T System. When the system is used in combination with either the QD Head Coil (MJQH-142A) or the Large Knee SPEEDER (MJAJ-182A), SAR values lower than the actual SAR values may be displayed on the operating monitor.
Spacelabs Healthcare elance Vital Signs Monitor with Option S, model 93330, is recalled because the monitor will not permit connection of any of the Spacelabs TruLink line of SpO2 sensors.
Firm was notified by supplier of xylanase enzymes that they were contaminated with Chloramphenicol.
''Wheat'' flour was not declared on the label
This voluntary recall is initiated because raw material used may contain trace amounts of the antibiotic chloramphenicol.