Recall Z-1701-2023 ยท EZD Catheter, Straight
C.R. Bard Inc
HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF 71814, e) REF 71816, f) REF 71818
| Date | Jun 8, 2023 (initiated Apr 20, 2023) |
| Status | Open, Classified |
| Reason | Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility. |
| Root cause | Under Investigation by firm |
| Action | The firm issued an URGENT MEDICAL DEVICE RECALL to its consignee beginning on 04/20/2023 by Fed Ex and email. The notice explained the problem, risk, and requested the following actions be taken: Discontinue distribution of the product and dispose of all affected product, Distributors are directed to notify their customers. For further assistance please contact: 1-844-8BD- LIFE (1-844-823-5433) Say "Recall" when prompted; M-F 8am - 5pm CT |
| Quantity | 308520 devices |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150345 | Magic3 Go Intermittent Urinary Catheter C.R. Bard, Inc., May 11, 2015 |