Recall Z-0464-2023 ยท OWL Peripheral Catheter Insertion Kit
Medical Action Industries, Inc. 306
Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), sterile; and Medical Action Industries Inc. IV Start Kit, REF #78019 (on kit label), sterile. Kit components are the Port Access Kit.
| Date | Dec 8, 2022 (initiated Oct 12, 2022) |
| Status | Terminated |
| Reason | The Port Access Kits were incorrectly labeled as IV Start Kits on the kit label. The case label was correctly labeled as Port Access Kits. |
| Root cause | Employee error |
| Action | The recalling firm issued a letter dated 10/12/2022 to their only consignee via email on 10/12/2022. The letter informed the consignee the kits were incorrectly labeled as reference number 78019, the IV Start Kit, but the case label correctly lists the item as the Port Access Kit. The consignee was requested to review their inventory and segregate and quarantine all affected kits labeled as IV Start Kit, lot #294589. If any of the affected kits were further distributed, the consignee was requested to ensure all end users were appropriately notified of the recall. The consignee was to conta |
| Quantity | 24 cases (480 kits) |
| Distribution | Distribution was made to MN. There was no foreign/government/military distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.