Recall Z-3129-2024 ยท FSM Tray, Surgical, Instrument
Medical Action Industries, Inc. 306
Foam Protective Pouches, model numbers 6010 (50 each/case), 6010-1 (350 each /case), 6060 (8 rolls/case), 6070 (75 each/case), 6106 (250 each/case), 6141 (250 each/case), 6203 (40 each/case), 6805 (50 each/case), 6805-1 (175 each/case), 6810 (50 each/case), 6810-1 (350 each/case), 6830 (8 rolls/case), and 6860 (8 rolls/case)
| Date | Sep 12, 2024 (initiated Jun 11, 2024) |
| Status | Open, Classified |
| Reason | The protective pouches were identified to have been improperly labeled with UDI that is associated with an incorrect GMDN (Global Medical Device Nomenclature) code. These blue foam pouches were misused due to misclassification of the GMDN. |
| Root cause | Under Investigation by firm |
| Action | Medical Action Industries notified consignees on 06/11/2024 via mail and email. Consignees were instructed to identify and quarantine any affected units in inventory, destroy all affected product, notify any customers if product was further distributed, and to complete and return the response form. |
| Quantity | 5,981,534 units |
| Distribution | Nationwide distribution. International distribution to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.