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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 3423 of 3462

Product Firm Event Initiated
CUSTOM CPB CATHETER KIT-DR. Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures. Terumo Cardiovascular Systems Corporation Event 61731 May 09, 2012
CPB CATHETER KIT-DR GERHARDT Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures. Terumo Cardiovascular Systems Corporation Event 61731 May 09, 2012
X-COATED H/L PK W/FX15RW40 Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures. Terumo Cardiovascular Systems Corporation Event 61731 May 09, 2012
XC HEART/LUNG PACK W/SX25RX Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures. Terumo Cardiovascular Systems Corporation Event 61731 May 09, 2012
CPB CATHETER KIT-DR BARTLES Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures. Terumo Cardiovascular Systems Corporation Event 61731 May 09, 2012
X-COATED TRANSPLANT PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures. Terumo Cardiovascular Systems Corporation Event 61731 May 09, 2012
CPB CATHETER KIT-DR VANTRIGHT Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures. Terumo Cardiovascular Systems Corporation Event 61731 May 09, 2012
X-COATED FX25RW H/L PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures. Terumo Cardiovascular Systems Corporation Event 61731 May 09, 2012
Dent's Extra Strength Toothache Gum, (benzocaine 20%), Net Wt. .035 Oz.. (1 g) box, C.S. Dent & Co., Erlanger, KY Grandpa Brands Co Event 61838 May 09, 2012
Oysters, IQF Standard, packed in 5 lb polyethlene bags, further packaged as 2 bags/box and 6 bags/box, and labeled in part ***Wanchese Fish Company 2000 Northgate Commerce Parkway, Suffolk, VA 23435*** Product of S Korea*** Wanchese Fish Company Event 62338 May 09, 2012
Oysters, IQF Select, packed in 5 lb polyethlene bags, further packaged as 2 bags/box and 6 bags/box, and labeled in part ***Wanchese Fish Company 2000 Northgate Commerce Parkway, Suffolk, VA 23435***Product of S Korea*** Wanchese Fish Company Event 62338 May 09, 2012
Oysters, Breaded IQF, 20-25 count, packed in 2 lb polyethylene bags, 5 bags/carton, and labeled in part ***Wanchese Fish Company, 2000 Northgate Commerce Parkway Suffolk, VA 23435***Product of S Korea*** Wanchese Fish Company Event 62338 May 09, 2012
ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc with Select a Flow and ONDEMAND Model/Reference #: 7000180, 7000181, 7000182, 7000367, 7000397, CB003, CB005, CB006, P400X1-7+5/60, P400X2-14+5/30, P400X5+5/60, and PMB01. Part Numbers: 101347100, 101347300, 101347400, 101360200, 101368400, 101368600, 101368700, 102987000, 102987200, 102987300, 103161800, 103534300, 5001438, 5001470, 5001651, 5001780, 5001808, 5001809, 5001812, 7000180, 7000181, 7000182, & 7000367. Indicated for continuous and or intermittent delivery of medication to or around surgical wound sites and or close proximity to nerves. I-Flow Corporation Event 62769 May 08, 2012
Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B12 Flex Reagent Cartridge used with the Dimension Vista System for the in vitro diagnostic test for the quantitative measurement of Vitamin B12 in human serum and plasma. Siemens Healthcare Diagnostics, Inc. Event 61889 May 08, 2012
Morton, Sodium Chloride, USP, Granular, packaged in kraft paper bags, fiber drums, and semi-bulk bags. Product is shipped in 80 lb bags, 350 lb drums & 2000 lb semi-bulk sacks. Manufactured by Morton Salt, Inc., Chicago, Illinois 60606-1743. Morton Salt Co. Event 61818 May 08, 2012
Estradiol Hemihydrate M20 EP/USP Powder, packaged in a) 1.5 kg and b) 2.5 kg fiber drums, Rx only, Art. No. 165811, Bayer Pharma AG, D-13342 Berlin. Bayer HealthCare Pharmaceuticals Inc. Event 62651 May 08, 2012
Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01%, Body Oil, 4 fl. oz. (118.28mL ), Rx only, FOR TOPICAL USE ONLY, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-150-04 Hill Dermaceuticals, Inc. Event 62607 May 08, 2012
Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01% Topical Oil (Scalp Oil), 4 fl oz (118.28mL) bottle, Rx only, FOR TOPICAL USE ONLY NOT, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-149-04 Hill Dermaceuticals, Inc. Event 62607 May 08, 2012
Frozen Salted Clam, 12/210g. Distributed by: Seoul Shik Poom, Engleside, NJ. Origin: Republic of Korea. Seoul Shik Poom, Inc. Event 62385 May 08, 2012
Frozen Oysters, Net Wt 1 LBS (454g). Distributed by: Seoul Shik Poom, Engleside, NJ. Origin: Republic of Korea. Seoul Shik Poom, Inc. Event 62385 May 08, 2012
POLVORONES AMARILLO QTY: 100 MEXICANTOWN BAKERY 313-894-2000 Mexicantown Wholesale Event 62055 May 08, 2012
MAGDALENA QTY: 54 MEXICANTOWN BAKERY 313-894-2000 Mexicantown Wholesale Event 62055 May 08, 2012
Panera HONEY WALNUT CREAM CHEESE SPREAD, Reduced Fat, 8 0z Refrigerated Panera Bread LLC Event 61831 May 08, 2012
CONCHA AMARILLA QTY: 90 MEXICANTOWN BAKERY 313-894-2000 Mexicantown Wholesale Event 62055 May 08, 2012
Panera ,HAZELNUT CREAM CHEESE SPREAD Reduced Fat, 8 0z , Refrigerated Panera Bread LLC Event 61831 May 08, 2012

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