Foam Protective Pouches, model numbers 6010 (50 each/case), 6010-1 (350 each /case), 6060 (8 rolls/case), 6070 (75 each/
FDA device recall Z-3129-2024 · posted 2024-09-12 · Open, Classified
Recall details
- Recalling firm
- Medical Action Industries, Inc. 306
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- FSM
- Quantity affected
- 5,981,534 units
- Distribution
- Nationwide distribution. International distribution to Canada.
- Date initiated
- 2024-06-11
- Date posted
- 2024-09-12
- Location
- Arden, NC
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