Recall Z-2388-2015 ยท KOD Catheter, Urological
C.R. Bard, Inc.
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supply Kit, Product Code 51614S. Intermittent catheter.
| Date | Aug 14, 2015 (initiated Jul 7, 2015) |
| Status | Terminated |
| Reason | Potential breach of the sterile barrier packaging. |
| Root cause | Unknown/Undetermined by firm |
| Action | A recall notice was sent to consignees on 7/7/2015 asking them to discontinue use of the product. The letter to the distributors requested a sub-recall. Both letters included a response form to be returned to Bard. |
| Quantity | 534,972 each |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000723 | HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC) Rochester Medical Corp., May 19, 2000 |