Recall Z-2804-2020 ยท NFK Kit, Repair, Catheter, Hemodialysis
Arrow International Inc
NextStep Retrograde Replacement Hub Set - Product Usage: is indicated for use in the replacement of a NextStep Retrograde hub connection assembly that has been damaged.
| 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
| K020430 | DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK) Diatek, Inc., May 9, 2002 |