Recall Z-1871-2017
C.R. Bard, Inc. · initiated March 9, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile.
Codes / lots: Product Code: A300316A, Lot number: NGAV2400
Reason for recall
Misbranded: Product labeled, Not made with natural rubber latex, may in fact contain natural rubber latex.
FDA-determined cause: Error in labeling
Action taken
Consignees were notified by letter on/about 03/09/2017.
Details
- Recall number
- Z-1871-2017
- Initiated
- March 9, 2017
- Product code
- EYZ – System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
- Quantity
- 5030 units
- Distribution
- CA, CO, FL, GA, IA, IL, IN, KY, LA, MI, MN, MS, NC, NE, NJ, NM, OH, OR, PA, RI, TN, TX, VA and WA.
- Recalling firm
- C.R. Bard, Inc., Covington, GA