Recall Z-0227-2023 ยท KOD Catheter, Urological
TELEFLEX LLC
Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.
| Date | Nov 11, 2022 (initiated Sep 20, 2022) |
| Status | Open, Classified |
| Reason | Product may not be sterile |
| Root cause | Nonconforming Material/Component |
| Action | Teleflex sent an URGENT MEDICAL DEVICE notice to its consignees on 10/03/2022 by Fed Ex 2nd day. The notice explained the problem and the hazard and requested the following actions be taken: "Action list number 1 Medical facilities 1. We request that you immediately check your inventory for product within the scope of this recall. Users should cease use and distribution of affected product and immediately quarantine the affected product. 2. If you have affected product, mark the applicable checkbox on the Acknowledgement Form (Appendix 1) and contact Teleflex Customer Service at the contac |
| Quantity | 7200 catheters |
| Distribution | TN, CA, NC, TX, FL, OH, MO, IL, OR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010420 | RUSCH MMG/O'NEIL CATHETER Rusch, Inc., May 9, 2001 |