Device product
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 10 Fr, (30/box), Product Code 51610. Intermittent catheter.
Z-2384-2015
Product summary
- Firm
- C.R. Bard, Inc.
- Event
- Event 71722
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14,310 each
- Official record key
device-enforcement:Z-2384-2015
Official wording
Reason: Potential breach of the sterile barrier packaging.
Code information: Lot Number 73600023
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