Recall Z-1431-2021 ยท KOD Catheter, Urological
C.R. Bard, Inc.
Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only.
| Date | Jan 11, 2021 |
| Status | Terminated |
| Reason | The device catheter tip was cut off (no tip) and the product packaging was not fully sealed. |
| Root cause | Packaging process control |
| Action | All customers will be contacted via letters sent via Fed Ex. The acknowledgement form included with the letter that is mailed or faxed back to BD will be reconciled with the customer list. BD will contact 100% of our customers that have not responded to the communication to verify acknowledgement. BD is requesting that customers discard affected components. |
| Quantity | 9,800 Units |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K802665 | TOUCHLESS CLEAN-CATH Diamed Division Ill. Tool Works, Inc., Nov 12, 1980 |