Medical Action Industries, Inc. 306: Device Recall
Recall #Z-3129-2024 · 06/11/2024
Class II: Risk
Recall Details
- Recall Number
- Z-3129-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Medical Action Industries, Inc. 306
- Status
- Ongoing
- Date Initiated
- 06/11/2024
- Location
- Arden, NC, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,981,534 units
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.
Product Description
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)
Distribution Pattern
Nationwide distribution. International distribution to Canada.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.