Recalling Firm
Community Blood Bank of Lancaster County Medical Society
Gorant Candies Inc A Division of Carlton Cards Retail Inc
LifeSouth Community Blood Centers Inc - Birmingham Region
Community Blood Centers of Florida, Inc.
D. D. Eisenhower Army Med. Ctr. - Blood Bank
Community Blood Centers of South Florida, Inc.
Bristol Myers Squibb Manufacturing Company
Medtronic Inc. Cardiac Rhythm Disease Management

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

Distribution Pattern
The recalled product was sold in Tropical's Outlet Store in Columbus, OH.
The product was distributed to one customer in Ohio.
The product was distributed in the states of OH, PA, MI, NY.
Product was distributed to wholesalers and retailers throughout the continental US and to Canada. US states product was distributed to includes: AL, AR, AZ, CA, CT, DE, FL, GA, IA, IL, IN, KY, MA, MD, MI, MS, NC, NE, NH, NJ, NY, OH, PA, SC, TN, TX, VA, WA, and WI.
The product was only distributed in the state of Kentucky.
Nationwide and Foreign (Canada, Israel, Singapore, and Switzerland)
Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Austria, Canada, Chile, Czech republic, Estonia,France, Germany, Hungary, Inida, Ireland, Italy, Japan, Libyan Arab Jamahari, Mexico, Netherlands, New Zealand, Norway , Oman, Panama, Peru, Poland, Qatar, Reunion, Russia, Saudi Arabia, South Africa, South Korea,Spain, Sweden, Swizerland, Thailand, UAE, and the UK.
Worldwide Distribution-USA (nationwide) and the countries of Argentina, Australia, Austria, Brazil, China, Czech Republic, France, Germany, Hungary, India, Ireland, Israel, Italy, Korea Republic, Malaysia, Netherlands, Russian Federation, Spain, Switzerland, Taiwan, Turkey, United Kingdom, and Viet Nam.
Worldwide Distribution - USA including the states of AR, CA, CO, FL, GA, IL IN, IA, LA, MD, MA, MI, MN, MO, NJ, NM, NY, NC, OH, OK, PA, PR, SC, SD, TN, TX and VA. and the countries of ALGERIA, AUSTRALIA, AUSTRIA, ARGENTINA, BELARUS, CANADA, CHINA, CHILE, EGYPT CZECH REPUBLIC, FRANCE, FINLAND, GERMANY, GABON, HONG KONG, INDIA, IRELAND, ITALY KENYA, KOREA, JAPAN, MEXICO, NIGERIA, PHILIPPINES, PORTUGAL REPUBLIC OF MALTA, RUSSIAN FEDERATION SAUDI ARABIA, SPAIN SWITZERLAND, TURKEY, TAIWAN, TUNISIA, UNTIED KINGDOM and VENEZUELA.
Worldwide Distribution - USA Nationwide including the states of CA, GA, LA, MA, MD, MI, MN, NH, PA, RI, TX, UT, WI and the countries of: Australia, CANADA, ENGLAND, JAPAN, KOREA, and SWITZERLAND.
Nationwide Distribution-including the states of CO, LA, MD, MN, NY, PA, RI, TN, TX and UT.
Nationwide; Jamica; Costa Rica; Egypt, El Salvador, St. Thomas, Venezuela, Ecuador, China and Guatemala
5 devices, all located outside of the United States in Germany.
Worldwide Distribution - USA including the states of AL, AT, AZ, BAH, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NJ, NV, NY, OH, OR, PA, PR, PR, SC, TN, TX, VA, VT, WA, WI & WV. and the countries of Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, China, Columbia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican, Republic, Ecuador, Egypt, Ethiopia, Finland, France, French Polynesia, Gabon, Georgia, Germany, Greece, Guadeloupe, Guinea, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, LAO People's Dem, Rep., Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malawi, Malaysia, Malta, Martinique, Mexico, Netherlands, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela & Viet Nam.
27 states (Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Louisiana, Massachusetts, Maryland, Maine, Mississippi, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia and West Virginia.
Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, 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; and, the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, GERMANY, GREECE, GUATEMALA, HONG KONG, HUNGARY, INDIA, INDONESIA, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KUWAIT, LIBYAN ARAB JAMAHIRIYA, MALAYSIA, MEXICO, NETHERLANDS ANTILLES, NICARAGUA, NICOSIA, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PROVINCE OF CHINA, PUERTO RICO, REPUBLIC OF KOREA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA &, YEMEN.
Worldwide Distribution - USA (nationwide) including the states of: CA, FL, GA, IL, KS, MA, MD, MO, NE, NY, and TX and the countries of: Canada, Germany, Romania, Spain, Palestine, South Africa, France, Sweden and Singapore
Mainly in TX but internet sales were nationwide.
Distributed in the states of MA,CA, and WI.
NY, PA, VA, TN, IN, MI, WI, MN, SD, ND, IL, MO, NE, KS, OK, TX, CA, WA
Nationwide Distribution including the states of MD, PA and TX.
Worldwide distribution, including USA nationwide, Albania, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Korea, Libya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Viet Nam.
USA Nationwide Distribution and the countries Europe, Belgium, Australia, and Latin America.
Worldwide Distribution - USA including Canada and the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, SK, TN, TX, UT, VA, VT, WA, WI, and WV.
Nationwide Distribution including MO, IL, FL, PA, VA, MO, NY, NE, NH, and OH.

Product Description
Red Blood Cells (Apheresis) Leukocytes Reduced
Red Blood Cells Leukocytes Reduced Irradiated
Blood and Blood Products for Reprocessing
Plasma Frozen within 24 hours after Phlebotomy (FP24)
Granulated Peanuts in 1 lb plastic bags.
B. A. Sweetie Double Dip Peanuts in plastic bags 2 lb, UPC 0 17598 90687 4, 5 lb, UPC 0 17598 00687 1; & Dave's Market Chocolate Double Dip Peanuts in plastic bags, 4 oz, UPC 017598 70687 0
B. A. Sweetie Chocolate Bridge Mix in plastic bags 2 lb, UPC 0 17598 90609 6, 5 lb, UPC 0 17598 00609 3; & Dave's Markets Chocolate Bridge Mix in plastic bags, 4 oz, UPC 017598 70609 2.
Sugar Free/ NSA Chocolate Bridge Mix in plastic bags 2 lb, UPC 0 17598 94258 2, 5 lb, UPC 017598 04258 9
Sweetie Sugar Free/ NSA Chocolate Peanuts in plastic bag 2 lb, UPC 0 17598 94259 9, 5 lb, UPC 0 17598 04259 6
Milk Chocolate Catalog # 111, Dark Chocolate Peanut Clusters Catalog # 112 & Peanut Butter Pieces Catalog # 107 individually wrapped. Date Codes 121401-130831
Chocolate bridge mix in 10 oz, 3 oz, and 3.5 oz bags
Milk Chocolate Peanuts in 10 oz, 3 oz, and 5 oz bags
No Sugar Added Milk Chocolate Peanuts in 10 oz and 3 oz bags
Yellow Corn Tortillas in 5 lb clear flexible plastic bags with green and yellow printing. Tortilleria Provincia 1200 B Clay Street Bowling Green, KY 42101
Fibrin Sealant (Human) Evicel Rx Only Sterile Disposable Single Use Distributed by: Johnson and Johnson Wound Management A division of Ethicon Inc. Johnson & Johnson Wound Management A division of ETHICON, INC. P.O. Box 151, Somerville, NJ 08876-0151 USA Manufacturer: omrix Omrix biopharmaceuticals, Ltd. MDA blood bank, Sheba Hospital Ramat-Gan POB 888, Kiryat Ono 55000 ISRAEL NDC 63713-390-55 for EVICEL Fibrin Sealant (Human) 5 mL NDC 63713-390-11 for EVICEL Fibrin Sealant (Human) 1 mL NDC 63713-390-22 for EVICEL Fibrin Sealant (Human) 2 mL
Thrombin, Topical (Human) EvithromRx only Distributor: Johnson & Johnson Wound Management A division of Ethicon, Inc. Manufacturer: Omrix Biopharmaceuticals Ltd. 2 mL - NDC 63713-460-02 5 mL- NDC 63713-460-05
HEXTEND 6% Hetastarch in Lactated Electrolyte Injection, 500 mL, Rx only , MANUFACTURED AND DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045, NDC 0409-1555-54
Philips Digital Diagnost Stationary radiographic system
ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka America Pharmaceutical Inc., Bristol-Myers Squibb NDC 59148-011-35
Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium.
0.9% Sodium Chloride Injection USP, 100 mL Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7984-23,
BD Vacutainer PST Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collection Tubes; Sterile; IVD; REF 367962; 4.5 mL, 13 X 100 mm; BD, Franklin Lakes, NJ USA; Made in USA. Used in hospitals, outpatient clinics and physicians' offices to collect blood from patients for specialized chemistry testing.
GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation 4.1) Volume Analysis (Advantage Workstation 4.0) Volume Analysis (Advantage Workstation 3.1) Advantage Windows Volume Rendering Option is intended to provide fast, easy, volume visualization of three dimensional structures imaged with a computed tomography (CT) or magnetic resonance (MR) system. It is dedicated to clinical and diagnostic applications in radiology, surgery, and treatment planning.
Macro Micro Subdural Electrode Product Usage: The AD-TECH Subdural Electrodes are intended for temporary (<30 days) use with recording, monitoring and stimulation equipment, for the recording, monitoring and stimulation of electrical signals on the surface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.
Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening.
Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966. For mandibular bone lengthening.
Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. For mandibular bone lengthening.
SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS system, Distributed by SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Manufactured by SIEMENS AG, MEDICAL SOLUTIONS, GERMANY.
Cold-smoked salmon in a vacuum packed, clear plastic bag. Product labeled: Csea brand Cold Smoked Smoked Sockeye Trim, 2 lb., Ingredients: Sockeye Salmon, Salt, and Natural Hardwood Smoked Produced by Ocean Beauty Seafoods, LLC KEEP REFRIGERATED AT 38 DEG OR BELOW''
Z Pro 25 High Protein Supplement Net. Wt. 1.3 oz. - Vanilla Flavor Formulated and Distributed by: R-Kane Products, Inc. 8351 National Highway, Pennsauken, NJ 08110
Z Pro 25 High Protein Supplement Net. Wt. 1.5 oz. - Chocolate Flavor Formulated and Distributed by: R-Kane Products, Inc. 8351 National Highway, Pennsauken, NJ 08110
Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System. The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
UpRiver brand Cold Smoke Atlantic Salmon Pre-sliced Vacuum Packed, 4 oz..
UpRiver brand Cold Smoke Atlantic Salmon Balik Cut Sides Vacuum Packed
Cold Smoke Atlantic Salmon Nordic Choice Pre-sliced Vacuum Packed
Cold Smoke Atlantic Salmon Trimmings Vacuum Packed
Deep Best Quality Dry Garlic Chutney (Thechaa); Net Wt. 4 OZ.; UPC 011433111201; Deep Foods, Inc. Union, NJ 07083
Well at Walgreens Wal-Tussin CF Max, MAXIMUM STRENGTH ADULT NON-DROWSY, Multi-Symptom Cold, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 8 FL OZ (237 mL) bottles, Distributed by: Walgreen Co, Deerfield, IL 60015 ---- NDC 0363-0229-08
Rite Aid Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg, 4 FL. OZ./12 PK (UPC Code: 0-11822-57307-8) and 8 FL.OZ./12 PK (UPC Code: 0-11822-57313-9), Distributed by: Rite Aid, Camp Hill, PA, 17011
Select Brand Cough Control CF Max, Maximum Strength for MUCUS RELIEF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 4 fl.oz 12pk (NDC 15127-025-04; UPC Code: 0-15127-02535-5), Distributed by: Select Brand Distributors, Pine Bluff, AR 71603 USA.
Wal-Mart Equate Tussin CF Adult Maximum Strength, Multi-Symptom Cold, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 8 FL OZ (235 mL) (NDC 49035-229-08; UPC Code: 6-81131-03884-30), Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72712.
Montelukast Sodium Tablets, 10 mg (base), packaged in a) 30-count tablets per bottle (NDC 68462-392-30) and b) 90-count tablets per bottle (NDC 68462-392-90), Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics Inc., USA, Mahwah, NJ 07430.
PROXIMATE Skin Staple Extractor,ETHICON ENDO-SURGERY, LLC Guaynabo, Puerto Rico 00969 USA Assembled in Mexico. For routine skin closure in a wide variety of surgical procedures.
D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone
D3000I Advantage Drive System, 230v Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone
Taco Seasoning, Net Wt. 1.25 lb and 5.75 lb. Distributed by Decoty Coffee Company, San Angelo, TX 76903, 800-588-8001. The products come in 1.25lb and 5.75lb sizes and are distributed in plastic spice containers with resealable lids.
Century Console Base, Model #043625051b Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.
ALL NATURAL ANCIENT GRAIN BREAD, NET WT. 13.8 OZ. (393 g), PRODUCT OF CANADA, UPC 0 49800 08712 5 (appears on bag), Product Code 08712 --- RICH PRODUCTS CORP., BUFFALO, NY 14213 --- The product is a frozen bread dough packaged in a plastic bag with 24 plastic bags per case. The frozen dough is sold to in-store bakeries and food service customers.
Sara Lee Thin Style Buns, 100% Multi-Grain, 1.5 oz., Goglanian Bakeries Product Code 77474, UPC 072945611788 --- The product is packaged in a plastic bag with a green bag clip. There are 8 buns per retail package (plastic bag) and there are 18 bags per tray.
Daphne's California 6 inch Multigrain Flatbread, 2.1 oz., Product Code 77468, Net Wt. 13.50 lbs. (case) --- There are 12 - 10 count bags per case
Atricure Inc. The Isolator Transpolar Pen is intended to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the AtriCure Ablation and Sensing Unit or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.
Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass procedures. Model numbers: 67312; 67314; CB67314; 67316; 67318; CB67318; 67320; 69312; 69314; 69316; 69318; 69320; 69322; 69324; 69328; 69331.
HERBALIFE Formula 1 Instant Healthy Meal, Nutritional Shake Mix ( Vanilla Dream) Packets; net WT 1.83 oz/52 g; packaged as 12 packets in a cardboard carton; just add water; single serve powder in a packet;
Hickman 9.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (pediatric product code 0600580; adult product code 0600600). Product Usage: Hickman and Leonard Catheters are designed for long-term vascular access and for use in patients that lack adequate peripheral venous access.
Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (product code 0600630). Product Usage: Hickman and Leonard Catheters are designed for long-term vascular access and for use in patients that lack adequate peripheral venous access.
AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities.
Food Club(R) MEXICAN STYLE ENCHILADA SAUCE, RED, NET WT 10 OZ (284g), DISTRIBUTED BY TOPCO ASSOCIATES LLC, 7711 GROSS POINT RD., SKOKIE, IL 60077UPC: 036800292208
Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports.
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules, 15 mg, Rx Only, C II, 100 capsules per bottle, MFG. By Actavis Elizabeth LLC. 200 Elmora Ave, Elizabeth, NJ, 07207, USA, NDC 0228-3063-11.
Medi-bolic Booster Injectable (methionine 8.3 mg/mL, choline chloride 16.6 mg/mL, inositol 16.6 mg/mL, cyanocobalamin USP [Vit B12] 0.33 mg/mL, chromium chloride 2.6 mg/mL), 30 mL multi-dose vials, Rx3 Compounding Pharmacy, 12230 Ironbridge Rd., Suite C, Chester, VA 23831.

Code Info
Peanut Butter Pieces Catalog #107, Milk Chocolate Clusters Catalog #111 & Dark Chocolate Clusters Catalog #112 Date Codes 121401-130831
Manufacture dates from 09/19/2011 through 10/19/2011 and all expiration dates between 10/19/2011 and 11/19/2011.
Evithrom 2mL Product Code S4602, Lot Number Q36T62K; Product Code 4602, Lot Numbers P49T05K, Q11T44J, Q2T46K, Q45T77J; Evithrom 5 mL Product Code 4605 Lot Numbers P46T84J, P50T150, Q07T23J, Q08T28K, Q23T88K, Q25T93J, Q25T94J, Q27T08J, Q30T31J, Q31T34J, Q31T360, Q32T41K, Q33T48J
All Digital Diagnost systems with Eleva software version 3.0.x
Reference No.: 367960; Tube Size: 13 X 75. Reference Nos. 367961-367963, and 368035; Tube Size: 13 X 100; all lots
All codes distributed between 1/1/2011 and 1/24/2013
Expiration dates: September 2012 - August 2017
The item code numbers are 71400 and 71410 with lot numbers from 010111 through 021313.
Product produced from July 27, 2012 through February 1, 2013 (Julian Dates 77002209 - 77003302)
Production Date Green Bag Clip Code 7/24/12 G01206Gxx* 8/1/12 G01214Gxx* 8/6/12 G01219Gxx* 8/30/12 G01243Gxx* 9/26/12 G01270Gxx* 10/17/12 G01291Gxx* 11/28/12 G01333Gxx* 12/16/12 G01351Gxx* 12/31/12 G01366Gxx* 1/18/13 G01018Gxx* (*xx denotes the hour of production and will be represented by two numeric digits (e.g. 09 would mean 9:00 a.m. production hour).
Production Date Bag Clip Code Case Jet Code09/06/2012 09/06/12 09/06/12 L1 HH:MM 11/13/2012 11/13/12 11/13/12 L1 HH:MM 01/20/2013 01/20/13 01/20/13 L1 HH:MM *HH:MM denotes the hour and minute of production and will be represented by four numeric digits (e.g. 09:20 would mean 9:20 a.m. time of production)
Model Number(s): MAX1 A000163, Lot Number 41865

Product Quantity
28 in U.S.; 4 Canada; 318 to other foreign countries.
205 of the 1.25 lb and 310 of the 5.75 lb

Reason for Recall
Blood product, manufactured from a unit of whole blood lacking hematocrit documentation, was distributed.
Blood products, which did not meet the acceptable product specifications, were distributed.
Blood product, which did not meet acceptable product specifications, was distributed.
Blood products, which did not meet the minimum requirement for total hemoglobin, were distributed.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Blood product, collected from a donor who lived in a country endemic for malaria, was distributed. .
Blood product, positive for the JKb-antigen but labeled as JKb-antigen negative, was distributed.
Blood product, positive for the E-antigen but labeled as E-antigen negative, was distributed.
Blood products, possibly contaminated with air during collection, were distributed.
Blood products, for which the required quality control testing was not performed, were distributed.
Blood product, positive for the c-antigen but labeled as c-antigen negative, was distributed.
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Blood products, which were exposed to unacceptable temperature during storage, were distributed.
Blood products, collected from a donor who was previously deferred, were distributed.
Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
The product is being recalled because it was manufactured using peanut products recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
Product is being recalled because it was manufactured using peanut products recalled by Peanut Corporation of America. The peanut products has the potential to be contaminated with Salmonella
This product is being recalled because it was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella
The product is being recalled because it was manufactured using peanuts that were recalled by Peanut Corporation of America because of their potential to be contaminated with Salmonella.
Blood products, collected from donors who did not have a complete physical exam, were distributed.
Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.
During an FDA inspection at the firm, it was discovered that the firm uses, FD&C Yellow #5, in the manufacture of their tortillas. However, FD&C Yellow #5 is not listed in the ingredient statement.
Evicel and Evithrom, manufactured with a processing deviation that potentially led to decreased potency, were distributed.
Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the bag.
Blood product, collected from a donor who had a previous history of travel to a malarial endemic area, was distributed.
Blood products, which were not quarantined subsequent to receiving post donation illness information, were distributed.
Blood product, labeled leukoreduced but was not tested to verify the White Blood Cell count, was distributed.
Blood products, which did not meet the acceptable product specifications for release, were distributed.
Platelet, with a low platelet count, was distributed.
Blood products, collected from a donor who had traveled to a malarial endemic area, were distributed.
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood products, collected from a donor considered to be at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
When the operator for a wall stand view selects an ''image rotation'' different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the wrong direction. When the operator manually rotates the image back, electronic side markers (if programmed) are rotated also and as a result may be placed in a wrong position inside the image.
CGMP Deviations: A drum of Abilify 30 mg Tablets rejected during the compression stage was not segregated from the other portion of the lot and was inadvertently shipped, packaged and distributed.
Due to a software data storage limitation which only occurs under certain conditions, measurements of the Reagent Blank (RB) or Calibration (CAL) sample results are not saved and the software reverts to a previously stored, acceptable RB/CAL result.
Lack of Assurance of Sterility: There is the potential for solution to leak from the administrative port to the fill tube seal.
BD is conducting a recall of the BD Vacutainer Plus Plastic Plasma Separator Tube (PST) with Light Green/BD Homogard Closure due to a deformed top of the tube reservoir reported in two customer complaints.
Incorrect views and measurements possible. GE Healthcare became aware of multiple potential safety issues involving the Advantage workstation, Volume Viewer Plus and Volume Analysis.
Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored.
The microelectrodes are not flush with the silastic substrate, may contain sharp edges capable of abrading the cortical surface, and may have remaining pieces which may fracture and remain in the cortical tissue with the electrode is explanted.
It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
Human Corneas, recovered from donors whose donor eligibility was not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed.
Siemens became aware of a potential safety issue when using the ''In-session resumption'' feature of the syngo RT Therapist (RTT) 4.3 software. The RTT will send again the previously completed beam or segment for delivery to the control console, thus repeating the already delivered Monitor Units of the same beam or segment.
A surveillance sample was found positive for Listeria monocytogenes.
Z Pro High Protein Vanilla Flavor Supplement is under recall because it contains the allergens milk and coconut, a tree nut, which are not declared on the label of the individual packets of the product.
Z Pro High Protein Chocolate Flavor Supplement is under recall since it contains milk and soy, allergens, which are not declared on the label of the individual packets of the product.
Incorrect values may be displayed. Philips is issuing a software update (version 4.5.5) to the Extended Brilliance Workspace (EBW) systems currently running software version(s) 4.0.2, V4.5.2 or V4.5.3, addressing a number of non-conformances.
Results from the company lab samples revealed that some of the samples contained Listeria monocytogenes.
Unapproved dye in product (Rhodamine B - Basic Violet 10).
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Chemical Contamination: The recall has been initiated based on multiple complaints received from pharmacists and consumers reporting that they detected an off-odor, described as moldy, musty or fishy in nature which has been identified as trace levels of Tribromoanisole (TBA) and Trichloroanisole (TCA).
Ethicon Endo-Surgery initiated a voluntary recall for all PSX Proximate Skin Staple Extractors because the possibility exists that damage to the packaging may have compromised the sterility of the device.
The Membrane Switch Panel (referred to as ''front panel'' of the component part number A34-003-207 is used on both the D3000 and D3000I Advantage Drive System, contained the incorrect symbology per third edition IEC60606-01 Medical Electrical Equipment: General requirements for basic safety and essential performance.
DeCoty Coffee Company of San Angelo, Texas is recalling its 1.25lb and 5.75lb of DeCoty Taco Seasoning because it contains an undeclared ingredient, Soy. People who have an allergy or severe sensitivity to Soy run the risk of a life threatening or serious allergic reaction if they consume these items.
Concerns that the addition of the UPS Battery Backup to the Century Console Base Shelf did not comply with the FDA premarket notification regulations.
Product was manufactured with bulk flour supplied by Dakota Specialty Milling which is being recalled due to reports of metal fragments..
The product was manufactured with bulk flour supplied by Dakota Specialty Milling. Dakota Specialty Milling is recalling the bulk flour because of reports of metal fragments (stainless steel) caused by a faulty mesh screen.
AtriCure has identified that products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.
Potential for uncharacteristically rough metal edges to occur along the inner diameter of the metal tip side ports of the cannula.
Herbalife of America Inc is initiating this recall due to trace amounts of an undeclared milk protein allergen.
Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual Lumen Catheters with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer Systems due to the wrong size introducer being included with the kit.
The control boards alarm set points and temperature tolerances allowed for erroneous activation of the AD (analog/digital) alarm as temperature fluctuated during operation. When this alarm occurs, the sterilizer locks up and cannot be used until serviced, causing Customer nuisance.
Undeclared soy and wheat: One can of product labeled as containing red enchilada sauce, was found to contain green enchilada sauce which contains wheat and soy.
The label on the device states that the item number is CLGY-2210 when the item number on the device label should read CLGY-2010. This is a 20Ga Huber needle set; however, the product label states the pouch contains a 22Ga set.
Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met.
CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures.