Device product
Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EX-Lok Sampling; Product Code 154006: Lot # NGYJ0603 and NGYJ1671
Z-1358-2015
Product summary
- Firm
- C.R. Bard, Inc.
- Event
- Event 70666
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,620 units
- Official record key
device-enforcement:Z-1358-2015
Official wording
Reason: Potential breach of the sterile barrier packaging.
Code information: Lot Numbers NGYJ0603 and NGYJ1671
Distribution pattern: Nationwide Distribution to the states of : AL, AZ, CA, FL, GA, IL, IN, KY, LA, MD, MA, MI, MN, MS, MO, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, VA, WV and WA.
Derived failure modes
-
Sterility assurance
breach of the sterile barrier