Device product
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supply Kit, Product Code 51614S. Intermittent catheter.
Z-2388-2015
Product summary
- Firm
- C.R. Bard, Inc.
- Event
- Event 71722
- Status
- Terminated
- Classification
- Class II
- Quantity
- 534,972 each
- Official record key
device-enforcement:Z-2388-2015
Official wording
Reason: Potential breach of the sterile barrier packaging.
Code information: Lot Number 53620387, 53621274, 53621279
Distribution pattern: Nationwide Distribution-including AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NV, NH, NJ, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI AND DC.
Derived failure modes
-
Sterility assurance
breach of the sterile barrier