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Recall Observatory FDA recall evidence

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Recalled products

The canonical enforcement rows. Everything else groups, enriches, or interprets these records.

Indexed record set

86,536 products

Page 3385 of 3462

Product Firm Event Initiated
Mercaptopurine Tablets, USP, 50 mg, packaged in a) 60-count tablets per bottle (NDC 49884-922-02) and b) 250-count tablets per bottle (NDC 49884-922-04), Rx only, Distributed by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977. Prometheus Laboratories Inc. Event 62772 June 29, 2012
Aloha Maid Natural brand Coconut Water with Pineapple in 11.5 fl oz (340mL) Can; UPC Code: 8-35146-00818-3; 24 cans per case (4 packs X 6 cans each) Product is processed and packaged by ITO EN (USA) INC., Honolulu, Hi Itoen (USA) Inc Event 62472 June 29, 2012
Earth's Best Organic Wheat Teething Biscuits, 6 pack, UPC # 23923-90015, HCG#C90615 Lovin Oven, LLC Event 63192 June 29, 2012
Designer Whey Strawberry, 2lbs, Item#10200137, 4 units/case. UPC 8-44334-00137-7. Designer Protein LLC Event 51820 June 29, 2012
Designer Whey French Vanilla, 2lbs, item # 10200133, 4 units/case. UPC 8-44334-00133-9. Designer Whey French Vanilla, 3lbs, Item#10200134, 5 units/case. UPC 8-4434-00133-10. Designer Protein LLC Event 51820 June 29, 2012
Dole brand Hearts of Romaine; Net Wt. 10 oz. UPC 71430 00956; Dole Dole Fresh Vegetables Inc Event 62455 June 29, 2012
21st Century Foods Soy Tempeh, packaged in 12 lb plastic bags and 8 oz containers 21st Century Foods, Inc. Event 62473 June 29, 2012
Designer Whey Chocolate, 2lbs, item#10200131, 4 units/case. UPC 8-44334-00131-5. Designer Protein LLC Event 51820 June 29, 2012
GE Healthcare, AW Server. Product Usage: . 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. GE Healthcare, LLC Event 64900 June 28, 2012
STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation kits and STERRAD test packs. The STERRAD CYCLESURE 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles. Advanced Sterilization Products Event 33854 June 28, 2012
VITROS Chemistry Products DGXN Slides --- [REF] 834 3386. Product is packaged in a box with multiple slides. The lot and expiration codes are found on the side of the package. Product Usage: Intended use: For in vitro diagnostic use only. VITROS Chemistry Products DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho-Clinical Diagnostics Event 62612 June 28, 2012
Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-3020-01 Mylan Pharmaceuticals Inc. Event 62911 June 28, 2012
Super Colon Cleanse, stimulant laxative, 140 mg of Senna per capsule, 25 doses, 100 capsules, Manufactured by: healthPLUS Inc. Chino, CA 91710 USA. Health Plus Incorporated Event 62442 June 28, 2012
BRD Oyster (Kaki) IQF Farm, BRD 106, 12/2lbs. Pacific American Fish Co Inc Event 38284 June 28, 2012
Frozen Fermented Salted and Seasoned Oyster, 39.7 lbs, 2 packs/container. SJBW Corp Event 62784 June 28, 2012
Oyster Half Shell Farm, OYS107, 144ps/cs, Oyster Half Shell small Farm, OYS114, 144ps/cs, Pacific American Fish Co Inc Event 38284 June 28, 2012
Oyster Meat Med IQF Farm, OYS101, 10/4lbs., Oyster Meat Large IQF Farm, OYS102, 10/4lbs., Oyster Meat Tiny 8oz IQF Farm, OYS105, 40/8oz., Pacific American Fish Co Inc Event 38284 June 28, 2012
Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106. Mar Cor Purification Event 67516 June 27, 2012
RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture, Cervical traction, Skeletal traction KCI USA, Inc. Event 62805 June 27, 2012
Powered Mobility Offers Versatility (M¿V)TM Chair. The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs. Stryker Medical Division of Stryker Corporation Event 61671 June 27, 2012
Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 Product Usage: The GSP instrument is a fully automated, high throughput batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The reagent kits running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders. Currently assays for the determination of T4, TSH, 17OHP, IRT and GALT are cleared and available for use with the GSP instrument. Perkinelmer Event 62512 June 27, 2012
Powered Mobility Offers Versatility (M¿V)TM Chair. The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs Stryker Medical Division of Stryker Corporation Event 61671 June 27, 2012
Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs. Stryker Medical Division of Stryker Corporation Event 61671 June 27, 2012
Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs. Stryker Medical Division of Stryker Corporation Event 61671 June 27, 2012
Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: The Micro-switch is used on the HOTLINE¿ 3 Blood and Fluid Warmer. This product, for use in conjunction with HOTLINE¿ 3 L-370 Fluid Warming Set are intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures. These products are intended for use by appropriately trained healthcare professionals in clinical environments Smiths Medical ASD, Inc. Event 62389 June 27, 2012

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