Recalling Firm
The American National Red Cross South Carolina Region
Community Blood Centers of South Florida, Inc.
Community Blood Centers of Florida, Inc.
Central Texas Regional Blood & Tissue Center
Thermo Fisher Scientific (Asheville) LLC
Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
F.H.G Corporation dba Integrity Nutraceuticals

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 DC, Puerto Rico, Virgin Islands and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV, and the countries of Canada, Columbia, Chile, Brazil, and Jamaica.
Product was distributed to Giant Eagle Stores in MD, OH, PA and WV.
Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV and Puerto Rico and the country of Canada.
Worldwide Distribution -- USA in the states of AR ,CA, CO, DC, FL, GA, HI, ID, IL, IN, KS, MA, MD, MI, MO, MS, NC, NE, NJ, NY, NV, OH, PA, TN, TX, VA, WA, WI, and WV, and the countries of Arab Emirates, Albania, Australia, Belgium, Brazil, Canada, Chile, China, Croatia, Czech., Denmark, Ecuador, Estonia, Finland, France, Germany, Hungary, Italy ,Korea, Kurdistan, Lebanon, Macedonia, Malaysia, Mexico, Norway, Oman, Poland, Russia, San Salvador, Saudi Arabia, Singapore, South Africa, Sweden, Turkey, Uruguay, Venezuela, and United Kingdom.
Nationwide Distribution including the states of AZ, CA, CO, FL, IA, ID, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NV, NY, OH, PA, RI, TN, TX, UT, VT, WA, WI, and WV.
Worldwide Distribution - USA (nationwide) including DC and PR and the countries of UKRAINE, TAIWAN, TURKEY, TUNISIA, THAILAND, SINGAPORE, SWEDEN, SAUDI ARABIA, RUSSIAN FEDERATION, PORTUGAL, POLAND, PAKISTAN, PHILIPPINES, PANAMA, NEW ZEALAND, NORWAY NETHERLANDS, MALAYSIA, MEXICO, MALTA, MARTINIQUE, MOROCCO, LATVIA, LITHUANIA, LEBANON, KUWAIT, KOREA, JAPAN, JORDAN, ITALY, IRAN, INDIA, ISRAEL, IRELAND, INDONESIA, HUNGARY, CORATIA, HONG KONG, GREECE, GEORGIA, UNITED KINGDOM, FRANCE, FINLAND, SPAIN, EGYPT, ECUADOR, ALGERIA, DOMINICAN REPUBLIC, DENMARK, GERMANY, CZECH REPUBLIC, CYPRUS, COLUMBIA, CHILE, SWITZERLAND, CANADA, CHINA, BRAZIL, BELGIUM, AUSTRALIA, AUSTRIA, ARGENTINA, SOUTH AFRICA, VENEZUELA, URUGUAY, ALGERIA.
Worldwide Distribution - USA (nationwide) including the states of: AL, AR, AZ, CA, CO, CT, DC, DE, 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, PR, RI, SC, SN, TN, TX, UT, VA, VT, WA, WI, WV & WY. and the countries: AFGHANISTAN, ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BRAZIL, CANADA, CHILE, COSTA RICA, DENMARK, EGYPT, ENGLAND, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, ICELAND, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KOREA, LEBANON, MALAYSIA, MEXICO, NEPAL, NETHERLANDS, NEW ZEALAND, NORWAY, PALESTINE, PEOPLES REPUBLIC OF CHINA, PERU, PHILIPPINES, PORTUGAL, QATAR, REPUBLIC OF PANAMA, ROMANIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, VENEZUELA, VIETNAM & WEST INDIES.
Worldwide Distribution -- USA, Asia Pacific, Canada, Europe, and Japan.
Nationwide Distribution including the states of NV, OK and PA.
Worldwide Distribution -- USA, Belgium, Great Britain, Italy, Kazakhstan, Latvia, Russia, Slovenia, Turkey, and South Africa.
Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, Belgium, Czech Republic, France, Great Britain, Poland, Albania, Austria, Bulgaria, Switzerland, Cyprus, Germany, Denmark, Estonia, Spain, Finland, Croatia, Hungary, Ireland, ITtaly Luxembourg, Latvia, Netherlands, Norway, Portugal, Romania, Serbia (Republic of Serbia), Sweden, Slovenia, Turkey, Ukraine, United Arab Emirates, Congo, The Democratic Republic of the (formerly Zaire), Kazakhstan, Lebanon, Russian Federation, South Africa, Mexico, Thailand, Brazil, China, Hong Kong, Israel, India, Japan, Malaysia, Panama, Singapore, Viet Nam.
AK, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, KS, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SD, TN, TX, UT, VT, WA, WI
Nationwide in US: LA, TX, TN, IL, MS, OH
Product was shipped to the following states: Illinois, Indiana, Kentucky and Ohio.
Worldwide Distribution - USA (nationwide) and internationally to Canada, Japan, Australia, China, New Zealand, France, Italy, Netherlands, Poland, Spain, Sweden, Switzerland and the United Kingdom.
Nationwide Distribution including the states of AK, GA, IL, KY, MA, NY, NC, RI, SC, TX, and VA.
Nationwide Distribution and Puerto Rico.
Nationwide Distribution including the states of WA, OH, CA, TX, WV, IL, AZ, CA, WI, ME, WI, NC, FL, MT, and HI.
USA Nationwide Distribution including the states of : IL, NH, MA, MI, MO, PR, NV, NM, MN, ID, NY, OH, NC, AZ, MS, LA, OR, PA, CA, and CT.
Distributed to only one consignee with several locations nationwide.
Nationwide Distribution including the states of CA, FL, GA, IA, IN, KS, LA, ME, MI, MO, NC, NH, NJ, NY, NV, OH, PA, TN, TX, VA and WA.
NC, MD, ID, FL, AR, PA, CA, CT, CO, IL, UT, NJ, IA, MS, Australia, Cook Islands
Worldwide Distribution, USA, including the states of AL, AZ, AR, CA, CO,K CT, DC, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT NE, NV N NJ, NM, NY, NC, ND, OH, OK, PA, RI ,SC, SD, TN, TX, VA, WA, WI and the countries of AUSTRALIA, AUSTRIA, BRAZIL, CANDA, CHILE, CHINA, COSTA ARICA, CROATIA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY INDIA, INDONESIA ITALY JAPAN, KOREA, LATVIA, LEBANON, MALAYSIA, MEXICO, MOLDOVA, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA , SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VIETNAM.
Worldwide Distribution - USA (nationwide) including the country of EU.
Distributed in the states of PA, IN, NY, CO, and CA.
Worldwide Distribution - USA (nationwide) the countries of: AE, AR, AT, AU, BA, BH, BM, BR, BS, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HR, HU, IE, IL, IN, IQ, IT, JO, JP, KR, KW, LB, LC, LV, MK, MX, MY, NL, NO, NZ, OM, PA, PE, PL, PR, PY, QA, RO, SA, SE, SG, SI, SK, SV, SY, TF, TH, TR, TT, TW, UA, UY, VE, ZA.
Worldwide Distribution - USA (nationwide) including the states of: AR, CA, GA, IL, IN,IA,LA, MA, MN, MT, NY, OH, PA, TX, VA and the countries of BELGIUM, BURKINA FASO, BRAZIL, CHINA, CANADA, SWITZERLAND, CHILE, COLOMBIA, CYPRUS, CZECH REPUBLIC, GERMANY, DENMARK, DOMINICAN REPUBLIC, EGYPT, SPAIN, FRANCE, UNITED KINGDOM, CHANA, GUADELOUPE, GREECE, GUYANA, HONG KONG, CROATIA, HUNGARY, INDONESIA, ISRAEL, ITALY, KUWAIT, LEBANON LUXEMBURG, LIBYAN, MOROCCO, MARTINIQUE, MEXICO, NETHERLANDS, NORWAY, PANAMA, PERU, POLAND, PORTUGAL , REUNION, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SUDAN, SWEDEN, SINGAPORE, SLOVENIA, SLOVAKIA, SIERRA LEONE, THAILAND, TUNISIA, TURKEY, VENEZUELA, MACEDONIA, PALESTINE, SOUTH AFRICA.
Worldwide Distribution - USA (nationwide) including the states of: AZ, CA, CO, FL, IL, MD, NJ, NY, OH, OK, TX. and the countries of Australia, Belarus, Canada,France, Germany, India, Japan, Lebanon, New Zealand, Saudi Arabia, Singapore, Spain, Sweden, Switzerland and United Kingdom.
Nationwide Distribution including DC and the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, ID, IL, IN, KS, KY, MI, MD, MN, MO, MT, NC, NJ, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA and WY.
Arizona, Califorina, Florida, Illinois, Maryland, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Virginia, Wisconsin,
USA Nationwide Distribution - including the states of: AK, AL, AZ, CA, CO, CT, DE, FL, GA, ID, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI & WV.
Worldwide Distribution - USA and countries of Australia, Austria, Bosnia Herzegovina, Belgium, Finland, France, Germany, India, Italy, Japan, Kuwait, Malaysia, Netherlands, Norway, P.R. China, Portugal, Rep.of Korea, Romania, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan and United Kingdom.

Product Description
Platelets Pheresis Leukocytes Reduced - Triple Product
Platelets Pheresis Leukocytes Reduced Irradiated
Red Blood Cells Leukocytes Reduced Washed
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood and Blood Products for Reprocessing
G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.
Giant Eagle Lotsa Chocolate Chip Cookies
Posey Biothane Restraint Cuffs, Catalog Number 2900. The device is intended to limit a patient's movement to the extent necessary for treatment or protection of the patient or others.
Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial thromboplastin time (APTT).
Leukotrap Blood Collection Systems with Flexible Y Connector, labeled as being manufactured by Medsep Corporation, A Subsidiary of Pall Corporation
ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Giraffe OmniBed and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***. GE Healthcare Giraffe Omnibed is a combination of an infant incubator and an infant warmer.
Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (non-locking) technique of treating stable diaphyseal fractures.
Canned Peach Slices in Light Syrup or canned Peach Slices in Heavy Syrup or canned Peach halves in Heavy Syrup. The PDP reads ''HOOD-CREST ELBERTA PEACHES YELLOW FREESTONE SLICES IN LIGHT SYRUP NET WT. 28 OZ. (1LB. 12 OZ.) 793G'' The back panel reads in part ''***INGREDIENTS: PEACHES, WATER, SUGAR. MUIRHEAD CANNING CO. The Dalles, Ore. 97058***'' The UPC on the label reads 7 88637 01111 7. The PDP reads ''HOOD-CREST ELBERTA PEACHES YELLOW FREESTONE SLICES IN HEAVY SYRUP NET WT. 28 OZ. (1 LB. 12 OZ.) 793G'' The back panel reads in part ''***INGREDIENTS: PEACHES, WATER, SUGAR. Packed by MUIRHEAD CANNING CO. The Dalles, Ore. 97058. There is no UPC on the label. The PDP reads ''HOOD-CREST ELBERTA PEACHES YELLOW FREESTONE HALVES IN HEAVY SYRUP NET WT. 28 OZ. (1LB. 12 OZ.) 793G'' The back panel reads in part ''*** INGREDIENTS: PEACHES, WATER, SUGAR MUIRHEAD CANNING CO. The Dalles, Ore. 97058***'' There is no UPC on the label.
Canned Pear Halves in Light Syrup or canned Pear Halves in Heavy Syrup. The PDP reads ''HOOD-CREST HALVES BARTLETT PEARS IN HEAVY SYRUP NET WT. 28 OZ. (1 LB. 12 OZ.) 793G'' and the back panel reads in part ''***INGREDIENTS: PEARS WATER, SUGAR. Packed by MUIRHEAD CANNING CO. The Dalles, Ore. 97058***'' There is no UPC on the label. For the light syrup the PDP reads ''HOOD-CREST HALVES BARTLETT PEARS IN LIGHT SYRUP NET WT. 28 OZ. (1LB. 12 OZ.) 793G'' The back panel reads in part ''***INGREDIENTS: PEARS, WATER, SUGAR. MUIRHEAD CANNING CO. The Dalles, Ore. 97058***'' The UPC on the label is 7 88637 01071 4.
Canned Apricot in Light Syrup or canned Apricot in Heavy Syrup. The PDP reads ''HOOD-CREST APRICOTS UNPEELED HALVES IN LIGHT SYRUP NET WT. 28 OZ. (1LB. 12 OZ.) 793G''. The back panel reads in part ''*** INGREDIENTS: APRICOTS, WATER, SUGAR. MUIRHEAD CANNING CO. The Dalles, Ore. 97058***'' The UPC is 7 88637 01031 8. The PDP reads ''HOOD-CREST APRICOTS UNPEELED HALVES IN HEAVY SYRUP NET WT. 29 OZ. (1 LB. 13 OZ.) with the back panel reading in part ''*** INGREDIENTS: APRICOTS, WATER, SUGAR Packed by MUIRHEAD CANNING CO. The Dalles, Ore. 97058***'' There is no UPC on the label.
GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera. Nuclear Medicine imaging systems. Recall includes all Infinia systems, all configurations.
CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381, 3307, 3308, 3310, 3311, 3540, 3541, 3542, 3543, 3584, 3585, 3598, and 3599. Product Usage: Incubators are designed to maintain an optimal environment for the incubation of tissue and cell samples. These models are designed to maintain temperature, carbon dioxide, and humidity levels.
Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm Product Code: 030450 Applications in abdominal, gynecologic, pediatric anti thoracic surgery for resection, transection and creation of anastomosis.
The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Product part's numbers: 3200731-xxx, 3202177-xxx, U3200731-xxx, and U3202177-006. Automated external defibrillators.
GREEN DAY brand White Melon Seeds, Net Wt. 9.8 oz (280g) , UPC 6 868978 724120, Produce of P.R.C. --- Firms on Label: Manufacturer: Jiangmen Xinhui Parksun Food Co., Ltd. Add: Donggua Hill, Beltou Village, Qibao, Xinhui District, Jiangmen City, Guangdong -- Packed For: Domega NY International Co., ltd. 1915 West 13th Street Brooklyn, N.Y. 11223 --- Nutrition Facts: Serving Size (illegible) Servings Per Container 4 --- The product is packaged in a clear, plastic bag on a plastic tray insert.
Cefdinir for Oral Suspension, 125 mg/5 mL, packaged in a) 60 mL bottle (NDC 0093-4136-64); b) 100 mL bottle (NDC 0093-4136-73), Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960.
Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52. Intended for use in reconstruction of the articulating surface of the acetabular portion of the hip.
Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc;Product Number: IAB-05830-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.
Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc;Product Number: IAB-05840-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.
Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC 0446 Rev 0. Used for cementation of all indirect restorations.
Blood bank software Primary Application with Model numbers 5.4.0; 5.4.0.1; 5.4.0.2; and 5.4.1
Blood bank software Primary Application 5.4.0.1; 5.4.0.2; and 5.4.1
Blood bank software Primary Application 5.4.0.2 and 5.4.1
Nutrex Research Lipo 6 Black Ultra concentrate Fat Destroyer
Portia (levonorgestrel and ethinyl estradiol) Tablets, USP, 0.15 mg/0.03 mg, 28-count tablets (containing 21 pink tablets followed by 7 white tablets) per blister card packaged in 6 blister cards per carton, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-9020-58.
Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 0.15 mg/0.03 mg, 91-count tablets per extended-cycle tablet dispenser packaged in 3 dispensers per carton, Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-9123-66.
NewChapter Probiotic Elderberry, 90 vegetarian capsules bottle.Dietary Supplement UPC: 7-27783-00123-8
Proti Diet High Protein Chocolate Dream Bar, is sold in 210 g packages (7 bars per package) UPC 6 21498 42238 1
Plasma Frozen within 24 hours (FP24) after phlebotomy, 281 ml from CP20 Whole Blood, Store at -18 degrees Celsius or colder.
Mikesell's Honey Barbecue TOMATO AND SPICES WITH A HINT OF SWEET FLAVORED POTATO CHIPS Gluten Free 1 oz., 2 oz., 6 oz., 10 oz., 16 oz. MIKESELL'S SNACK FOOD CO. P.O. BOX 115 DAYTON, OH 45404.
IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management.
Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA A subsidiary of Stryker Corporation. Made in USA. Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex France The Baseplate Impactor Extractor is intended to securely attach to the tibial baseplate or baseplate trial for impaction and extraction during surgery.
IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.
Precise Treatment Table. To be used as part of radiation therapy treatment process.
T SX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. Designed to produce cross-sectional images of a human body.
MRT-1504/A4 - Titan X MRI SystemMRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System.
Ferrous Sulfate Tablets 325 mg, 100 count bottles, Nutritional Supplement. Label reads in part ''OPTIMUM *** FERROUS SULFATE 325 * mg 5 Grain *** Gluten Free Dietary Supplement *** Manufactured & Distributed by: Magno-Humphries Labs Tigard, OR 97223 U.S.A. *** *325 mg calculated as Ferrous Sulfate Heptahydrate. ***'' UPC 0 43292 56306 0 There are 72 bottles per shipping case and most product is shipped by case.
Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.
Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select. Angiographic x-ray system.
Sunchang Ssamjang Sesame and Garlic Seasoned Bean Paste 500 g - Net Wt. 17.64 oz., UPC Code 880152435671 Distributed by: Daesang America, Inc. Hackensack, NJ 07601 TEL: (201) 488-4010 Product of Korea
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP, 20 mg/25 mg, 100 (NDC 60429-046-01) and 1,000 (NDC 60429-046-10) count bottles, Rx only, GSMS Inc., Camarillo, CA
MUSCLEPHARM brand COMBAT POWDER (R), COOKIES 'N' CREAM, NATURAL AND ARTIFICAL FLAVORS, HYBRID SERIES DIETARY SUPPLEMENT, NET WEIGHT 2 LBS (907 GRAMS), EXCLUSIVELY DEVELOPED AND MANUFACTURED FOR: MUSCLEPHARM(TM) CORP., 4721 Ironton St., Denver, CO, 80239, UPC 736211050670
MUSCLEPHARM brand COMBAT POWDER (R), BANANA CREAM, NATURAL AND ARTIFICAL FLAVORS, HYBRID SERIES DIETARY SUPPLEMENT, NET WEIGHT 2 LBS (907 GRAMS), EXCLUSIVELY DEVELOPED AND MANUFACTURED FOR: MUSCLEPHARM(TM) CORP., 4721 Ironton St., Denver, CO, 80239, UPC 736211050571
GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ S7 (with software revisions R1.0.1, R1.0.2 and R1.0.3) diagnostic ultrasound system with the S4-10-D Ultrasound Probe. The device is intended for use in ultrasound evaluation.
Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are intended to hold in orthodontic wires used to move teeth during orthodontic treatment
NatureBox brand Umami Almonds packed in branded stand-up pouches (whole tamari flavored almonds), Net wt. 4.3 oz. No UPC Codes on the product, Product is processed and packaged by NatureBox, San Carlos, CA; NOTE: Product label DOES declare that it is ''Packed in a facility that also processes tree nuts, peanuts, milk, wheat, and soy'' below the ingredient statement.
Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of the patient. .
Medtronic MiniMed Paradigm Insulin Infusion Pumps Model Numbers: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754. Product Usage: Paradigm insulin infusion pumps are intended for use to deliver basal and bolus insulin to persons with diabetes.
Product does not have a label. The consignees are provided with an ingredient statement for all the products they purchase. The product is packaged in a reusable plastic tote, with white sticker applied to one side of tote. This sticker has the Prepared Date: which is hand written as the month-day.
VMX, VMX Plus Mobile Radiographic Unit with the following models:45296139; 45296200; 45296350; 45296477; 45296964; 45297001; 45296966; 45297003; 2240169; 2240171; 2240172; 2240173. Product Usage: The VMX is a mobile radiography system incorporating stylish design for totally adapted use in intensive care, emergencies, pediatrics, neonatology and orthopedics.
GE Healthcare, Discovery MR750w 3.0T System. Part Number: 5352293. Product Usage: It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra,dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate,blood vessels, and musculoskeletal regions of the body.
LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povidone Iodine, antiseptic towelette. Kit Number: 2113110. First Aid Kit.
LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Number: 2113305. First Aid Kit.
LHB, First Aid Type I Individual Kit, NSN: 6545-00-656-1092, antiseptics, Kit number: 2114002. First Aid Kit.
LHB, Perishable Items Pack Type I , Kit Number: 2114002-100. First Aid Kit.
LHB, First Aid Type III, NSN # 6545-00-656-1094, Kit number: 2114011. First Aid Kit.
LHB, Perishable Item Pack Type III. Kit number: 2114011-100. First Aid Kit.
LHB, First Aid Type IV Belt Type, NSN #6545-01-010-7754. Kit number: 114016. First Aid Kit.
LHB, Perishable Items Pack Type IV. Kit number: 2114016-100. First Aid Kit.
ShanTea Enlightened Mind Mate/Kukicha (UPC 794504284102) USDA Organic.
ShanTea Ride The Dragon Honeybush/Licorice (UPC 794504283808) USDA Organic.
Large Cheese Crisp & Burrito Size, one dozen, net wt. 30 oz
Lite Thin Tortillas, one dozen., net wt. 15 oz
Small Flour Gorditas, one dozen, net wt. 24 oz
Torrent'' irrigation tubing. Product Usage: The Torrent irrigation system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit.
Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains version 4 of the MPI board 10434200; The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Code Info
The model/catalog number for the device is 2900. All lots are being recalled.
12092 BLOOD BAG CP2D/AS3 DBL 500 SP; 12193 BLOOD BAG CP2D/AS3 TR500MLSP; 12194 BLOOD BAG CP2D/AS3 QD500MLSP; 12393 RC-PL TRIP CP2D/AS3 SDP; 12394 RC-PL QUAD CP2D/AS3 SDP; 12593 PL TRIP CP2D/AS3 500ML SDP; 12594 PL QUAD CP2D/AS3 500ML SDP; 12692 WBV DBL CP2D/AS3 500ML SDP; 12693 WBV TRIP CP2D/AS3 500ML SDP; 12992 RC2D DBL CP2D/AS-3 500ML SDP; 12993 RC2D TRIP CP2D/AS3 500ML SDP; 12994 RC2D QUAD CP2D/AS3 500 ML SDP; 13092 BLOOD BAG CPDA-1 DBL 500 SP; 13692 WBV DBL CPDA-1 500ML SDP; 13693 WBV TRIP CPDA-1 500ML SDP; 13694 WBV QUAD CPDA-1 500ML SDP; 62692 VWB CP2D/AS3 DBL 500ML SDP; 62693 VWB CP2D/AS3 TRIP 500ML SDP; 62993 RC2D TRIP CP2D/AS3 500ML SDP; 72092 BLOOD BAG CP2D/AS3 DBL 450 SP; 72193 BLOOD BG CP2D/AS3 TRP 450ML SP; 72292 RC DBL CP2D/AS3 450ML SDP; 72393 RC-PL TRIP CP2D/AS3 SDP; 72663 VWB,CP2D/AS-3 TRIPLE 450ML SDP; 72663 QVWB,CP2D/AS-3 TRIPLE 450ML SDP; 72692 WBV DBL CP2D/AS3 450ML SDP; 72692 RE02699 WBV DBL CP2D/AS3 450ML SDP; 72693 WBV TRIP CP2D/AS3 450ML SDP; 73092 BLOOD BAG CPDA-1 DBL 450ML; 73692 WB V DBL CPDA-1 450 ML SDP; 73694 CDPA-1, 450 ML CAPACITY, QUAD; ATSBC1EB FILTSYSHELEUKO ATS BC PL BL LB; ATSBC1EPSL FILT SYS HELEUKOATSBCPLW/NDL L; ATSBC1ESB FILT SYS HELEUKOATSBCPLW/NDL B; ATSBC1ESN FILT SYS HELEUKOATSBCPLW/NDL N; ATSBC1EU FILTER SYSTEMLEUKOATSBCPLUK LB; ATSBCIESB FILT SYS HELEUKOATSBCPLW/NDL B; BCT0EUPRC BCT0EUPRC - TORNIER EU; BPF4BWL FILT BLOODPROCSET BPF4 LEUKO L; C-PET FILTER HARVEST SET; NFB434CCL T&B QUAD CPD/SAG-M 450 ML; NFB434CCLRE2691 T&B QUAD CPD/SAG-M 450 ML; RC2VAYE F PURECELLRC2F/BLOODW/YSETEULB; RCB434CCL T&T QUAD WB CPD/SAG-M 450ML; RCB434CCL T&T QUAD WB CPD/SAG-M 450ML; RCB434CCLS T&B QUAD RCS CPD/SAG-M 450 ML; RCB434CEL RCT&B4PVCBAG63MLCPD/100MLSAG-M; RCB434CEL3 RCT&B4PVCBAG63MLCPD/100MLSAG-M; RCB434CUP RCT& B4PVCBAGS63MLCPD/100ML SAG; RCB436CCU RED CELL SYSTEM; RCB436CCURE2700 T&B QUAD RC CPD/SAG-M 450 ML; RCB436CCURE2701 T&B QUAD RC CPD/SAG-M 450 ML; RCB436CCURE2721 T&B QUAD RC CPD/SAG-M 450 ML; RCB436CCURE2727 T&B QUAD RC CPD/SAG-M 450 ML; RCB436CCURE27
Peach Slices in Light Syrup has a can code: fairtime 264 12:24.Peaches Slices in Heavy Syrup has a can code: elberta 265 12:24. These codes are interpreted as: Fairtime or Elberta peach type, Julian date 264 or 265, and processing time. The firm has not provided the code information for the peach halves.
Pear Halves in Light Syrup has a can code: bartlett 285 12:24. This code is interpreted as: Bartlett type, Julian date 285, and processing time. The can code for Pears in Heavy Syrup is: BARTLETT 285 12:12
Apricots in Heavy Syrup has a can code: paterson 195 12:24. This code is interpreted as: Paterson apricot type, Julian date 1955, and processing time. Apricots in Light Syrup's can code: PATERSON 195 12:12.
Lot Codes:N2F0563LX, N2F0341LX, N2F0725LX, and N2E0605LX.
Lot: 01230049332Expiration date: 01/31/15 (located on the bottom of the box and on the side of the bottle)
Lot code CR 18 13B, and Best Before: 2015-08.
Softwaer version: IMPAX CR 7.8 SU3 Optical Character Recognition (OCR) Service
Model # L9M21000. Software versions: IMPAX CV 7.8, 7.8 SU1, 7.8 SU2 and 7.8 SU3, IMPAX CV 7.8 SU2.5 with IMPAX CV Outbound Report Stylesheet 7.8_HL
The majority ofthe letters are sent via USPS return receipt mail. The letter contains a return reply formthat is to be faxed to TAMS for retention. After two weeks contact will be made with each nonresponding location and a copy ofthe letter will be faxed to that location and the fax receipt will serve as proof ofnotification.
Product code -L6430-100-01(L is designate label, 6430 is the firm's internal product code, 100 is for 100 count and 01 stands for Optimum label, and 0 is the firm's version number. All of these products have the same label code, however; they have different lot numbers. Lot Numbers: 343617, 343718, 343739, 343753, 343814, 343888, and 343959. Expiration dates 11/15, 12/15, 12/15, 12/15, 12/15, 1/16 and 1/16 respectively (expiration dates are month and year) The lot number and expiration date is stamped on the bottom of the bottles.
All expiration dates. Recalled product was distributed from June 2012 to Feb. 2013.
Part Number 438-0184 Lot Number 051063597
All lot codes with Best By Dates or 5/15/13 or earlier.
All kits shipped between 1/12010 through 3/4/2013.

Product Quantity
firm is unable/unwilling to provide this information
54,197 units in US and 78,627 units internationally (total 132, 824 units)
37 cases (30 x 280 gram packages per case)

Reason for Recall
Blood products, which were collected from a donor who traveled to malarial endemic areas, were distributed
Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Blood product, for which storage condition was outside the acceptable range, was distributed.
Blood products, prepared without the appropriate amount of additive added and/or incorrectly added, were distributed.
Blood products, which did not meet the acceptable product specifications, were distributed.
Blood product, which was in transit greater than 24 hours, was distributed.
Blood products, which did not meet acceptable product specifications, were distributed.
Blood product, which was collected from a donor who traveled to malarial endemic area, was distributed
Blood products, which may have been exposed to unacceptable temperature during storage, were distributed.
Blood products, collected from a donor who was previously deferred, were distributed.
Blood products, which failed to meet the minimum specification for product volume, were distributed.
Blood products, where quality control and distribution of products did not meet specifications, were distributed.
Blood products, in which QC was not performed or unacceptable for West Nile Virus, were distributed.
Blood products, for which shipping and storage conditions were undocumented, were distributed.
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood products, which did not meet the acceptable product specifications for release, were distributed.
Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Blood products, collected from a donor who was permanently deferred, were distributed.
Inspectional observations made during establishment inspection include Quality System Regulation deficiencies found that several undocumented and unreported corrections were made to a device. These corrections may constitute changes to the device that may require the submission of a new 510(k).
Labels do not accurately state ingredients/nutrition facts/allergens. An incorrect label was placed on this product that does not declare soy lecithin while the actual product contains soy lecithin.
The firm voluntarily recalled Biothane Restraint Cuffs, Catalog No. 2900, that did not meet the required specifications for tensile strength. Failure of these rivets could allow the cuff to become disconnected from the connecting strap and allow patients to regain free use of the limb.
Siemens has observed that the listed lot numbers show an increase in Heparin sensitivity over the shelf life which is demonstrated by testing with Dade(R) Citrol(R) Heparin Control, low and high.
Whole Blood Collection Sets, with a potential for a leak to occur in the flexible Y connector of the donor line, were distributed.
A potential safety risk with the MOSAIQ OncologyInformation System that has been identified by the manufacturer IMPAC Medical Systems, Inc.
Blood products, which were collected from a donor who traveled to malarial endemic area, were distributed.
Blood product, collected that did not have WBC QC testing for contamination, was distributed.
Neonatal beds and incubator display boards may randomly overwrite stored information and radiant heater and oxygen set points upon power up or recovery from a power failure.
Synthes is initiating a voluntary recall of the Flexible Grip (Part number 355.28) which is part of the Universal Nail System, due to the potential lack of the ability to thoroughly clean the instrument.
potentially under processed and reports of swollen and bursting cans as well as discoloring fruit soon after opening the can and the fruit is undercooked (too firm), from consumers.
Potentially under processed and reports of swollen and bursting cans as well as the fruit turning brown shortly after opening and the fruit is undercooked (firm) from consumers.
Potentially under processed and reports of swollen and bursting cans as well as fruit browning quickly after opening the can and undercooked (firm) fruit from consumers.
Accelerated fatigue of the lateral axis motion subsystem of the Infinia Computed Emission Tomography System could result in mechanical failure causing the detector to slide; may impact patient and operators.
Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in the field.
Single Use Loading Unit contained two staples loaded in each cartridge pocket and may result in difficulty firing and removing the device from the application site, which may require medical intervention
LIFEPAK CR Plus or LIFEPAK Express Automated External Defibrillators (AEDs) are recalled due to the potential to experience an early internal battery depletion issue.
The product contained undeclared sulfites (1539 ppm) based on sampling & analysis by New York State Department of Agriculture & Markets.
Defective Container: This recall is being carried out due to the potential for improperly sealed bottles.
Firm was made aware of incidents relating to the difficulty of properly engaging and securing the Cross-Over 36mm liner into the Cross-Over shell.
Allergenic Extracts, reprocessed by an unapproved process, were distributed.
Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement ofthe catheter.
Kerr Corporation is initiating this recall because raw material used to produce the Maxcem Elite is causing the material to prematurely polymerize in the syringe. The product could be difficult to extrude or demonstrate a shorter work-time as the material may prematurely set prior to placing restorations on the tooth or core build-up. As a result, the restoration may not be seated properly.
Blood Bank Software, with a defect or glitch, was distributed.
Blood Bank Software with a defect or glitch, was distributed.
Product samples contain DMAA (Methylhexanamine).
Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
The product may contain an undeclared allergen soy
Product may be contaminated with Salmonella
Unlicenseed blood products were distributed in interstate commerce.
The firm received complaints of illness involving the product. Further investigation revealed that the package was mislabeled as ''Gluten Free''
Software design error in IMPAX CV 7.8 SU3
Stryker received reports from the field indicating that the handle detached from the cam of the Baseplate Impactor/Extractor Assembly.
Baseline pulmonary capillary wedge (PCW) pressure values from IMPAX CV Reporting Cardiac Catheterization module were not correctly transferring into the hospital's electronic health record (EHR) system.
Human tissue allograft, recovered from a donor whose donor eligibility determination did not confirm the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseeases, was distributed.
The Column rotation can accidentally be moved to a different position which in the locked position.
It was found that in vHP scan, the estimated DLP (total exposure dose of all scans in a singleexamination) value displayed in the eXam Plan window in scan planning and the DLP value displayed in the summary after scanning are incorrect.
It was found that there is a problem with the LCD monitor used in the console. The LCD monitor maybecome blank during use. Specifically, the backlight of the LCD monitor may turn off while the system is in use, causing the LCD monitor to become blank. However, the other parts of the system continue to operate normally, and the risk of a serious health hazard is therefore very low. The LCD Monitor will be replaced with a new monitor.
The firm found minute pieces of blue material identified by their raw material supplier as polypropylene, a relatively inert plastic.
It has been found that due to a problem with the control software of the x-ray high-voltage generator, if scanning is performed with a tube current less than 30mA, the control software may detect an error and perform error processing even though the x-ray output is normal.
Siemens has become aware of a potential malfunction and possible hazard to patients and staff when using the Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select. This malfunction is possible in cases where the table vertical lift movement is obstructed by a solid object which could potentially result in collision. This can result in damage to system mechanics that may not necessarily prevent the table from functioning immediately, but can lead to complete failure of the table mounting mechanics. It is possible that the table may drop, resulting in potentially hazardous situations for patients and/or staff.
Sesame and Garlic Flavored Mixed Soy Bean Paste contains peanut powder which is included in the Korean ingredient listing but not the English ingredient listing.
Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets by the manufacturer
One lot of each product may have extraneous materials due to a problem on the packing line.
GE Healthcare has become aware of a potential safety issue due to the S4-10-D Ultrasound Probe used in conjunction with the LOGIQ S8 and LOGIQ S7 Ultrasound systems. It was also discovered that this issue also leads to a specification issue of the acoustic output of this probe. There is a potential for a skin burn when the flow model in the cardiac application is activated with the S4-10-D Ultrasound probe.
Ormco Corporation is voluntarily recalling one (1) lot of Bracket Buccal Tubes as a result of a packaging error. More specifically, the BracketBuccal Tubes product package correctly identifies the product as gingival (0) offset brackets, but actually contains distal (10) offset brackets. Use of the affected product may cause unintended rotation of the molars. Although reversible, a delay in treatment could occur.
Product may contain wheat allergen. Wheat is not listed in the ingredient statement.
The mask inside the package has been identified as ''Neonatal'' in size and not ''Infant'' as the labeling indicates.
Medtronic is recalling the Medtronic Paradigm Insulin Pump because the pump's drive support cap may become detached from the pump case and protrude from the lower right side of the pump. When the pump is expose to water it may result in damage to the pump's internal electronics. This moisture damage can prevent the pump's buttons from working properly or can cause the pump to alarm.
There is the possibility of what appears to be plastic/paint shavings in the container holding the raw cookie product.
GE Healthcare has become aware of an issue associated with the base casting for the articulated arm of your VMX andVMX Plus Mobile X-ray systems that may impact Operator or Patient safety.
GE Healthcare has recently become aware of a potential issue due to image flip in frequency encoding direction associated with a specific workflow of your Discovery MR750w system.Image flip issue in frequency encoding direction (including S/I, A/P and R/L) can result in incorrect localization of anatomy and pathological findings.
The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterilized. Some product labeling states ''Sterility guaranteed unless seal broken'' or ''Contents sterile if package is intact.'' These claims were intended to indicate surface sterilization only but could mistakenly lead to the conclusion that the drug product solution is sterile. It was determined that labeling on certain products could be misleading in relation to sterility claims.
This recall has been initiated due to the potential for the possibility of Salmonella contamination.
Red Eagle Enterprises is recalling Red Eagle Brand Flour tortilla products because they contain undeclared wheat.
The firm was notified by their customers that there was a water leakage from the white tubing connector.
When using the V5M transducer, the display of the temperature on the ACUSON SC2000 system can be lower than the actual temperature of the V5M transducer. This occurs only if the system hardware contains revision 4 of the MPI Board. There is a potential to cause esophageal burns in patients.