Device product
SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile.
Z-1871-2017
Product summary
- Firm
- C.R. Bard, Inc.
- Event
- Event 76775
- Status
- Completed
- Classification
- Class II
- Quantity
- 5030 units
- Official record key
device-enforcement:Z-1871-2017
Official wording
Reason: Misbranded: Product labeled, Not made with natural rubber latex, may in fact contain natural rubber latex.
Code information: Product Code: A300316A, Lot number: NGAV2400
Distribution pattern: 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.
Derived failure modes
-
Labeling or packaging
Misbranded