Recall Z-0147-2022 ยท PEZ Central Venous Catheter Dressing Change Kit
Medical Action Industries, Inc. 306
Kit: Central Line Dres Change 20/Cs
| Date | Sep 8, 2021 |
| Status | Terminated |
| Reason | The ChloraPrep 3ml kit component has a shorter expiry date than the labeled kit expiry date. |
| Root cause | Process control |
| Action | A customer email was sent to the impacted distributor dated 09/16/2021. The distributor was notified of the recall issue and instructed to inventory and segregate affected product. Warning labels were provided and are to be affixed to the affected kits. Relabeling should be conducted in a manner that does not allow other pertinent labeling information to be covered up. The distributor was also notified that the recall should be carried out to the end user level. |
| Quantity | 42 cases |
| Distribution | Distribution to a single US distributor in Michigan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.