Recall Z-2803-2020 ยท CAZ Anesthesia Conduction Kit
Arrow International Inc
Arrow TheraCath Epidural Catheter - Product Usage: The Arrow Epidural Catheter permits access to the epidural space.
| Date | Jul 6, 2020 |
| Status | Terminated |
| Reason | The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection or other complications. Sterility, biocompatibility, safety, or efficacy of the kits and their components are not assured beyond the correct expiration date. |
| Root cause | Incorrect or no expiration date |
| Action | Arrow sent a customer notification letter dated July 6, 2020. This letter informed customers of the affected product, asked them to check and remove inventory, and complete the response form. |
| Distribution | World wide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K801912 | ARROW POSITIVE PLACEMENT CON/EPIDURAL AN Arrow Intl., Inc., Sep 16, 1980 |