Recall Z-0666-2022 ยท KOD Catheter, Urological
C.R. Bard Inc
BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C
| Date | Jan 27, 2022 |
| Status | Terminated |
| Reason | There is a potential to leak from the catheter where it connects to the drain bag |
| Root cause | Under Investigation by firm |
| Action | The firm initiated the recall on 01/27/2022 by letter. The letter explained the issue and the hazard and requested consignee destroy any product on hand. Distributors were directed to destroy all product on hand and to notify their customers of the recall. |
| Quantity | 2120 units |
| Distribution | US Nationwide distribution in the states of GA, ME, NJ, WI, MN, SD, CO, ND, ID, IL, FL, LA, MD, PA, OH, NE. |
| 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 |