Recall Z-0751-2023 ยท OFD Catheter Introducer Kit
Medical Action Industries, Inc. 306
Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter introduction kit
| Date | Dec 21, 2022 (initiated Nov 4, 2022) |
| Status | Terminated |
| Reason | XXX |
| Root cause | Under Investigation by firm |
| Action | The recalling firm issued an URGENT: MEDICAL DEVICE FIELD CORRECTION to its sole consignee by email on 11/04/2022. The notice explained the issue and request the following actions be taken: "Please review your inventory, and segregate and quarantine all affected Kits. If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. A labeling template for each LOT is enclosed for printing labels which can be affixed on all affected kits in inventory. This label should be applied to each affe |
| Quantity | 198 cases |
| Distribution | US Nationwide distribution in the state of VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.