Z-3129-2024 Class II Ongoing
FDA device recall Z-3129-2024 was initiated by Medical Action Industries, Inc. 306 on June 11, 2024 and is designated Class II. 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 misus… The recall status is ongoing. Affected quantity: 5,981,534 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 18, 2024
- Initiation Date
- June 11, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,981,534 units
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)
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.
Distribution Pattern
Nationwide distribution. International distribution to Canada.
Code Information
Model Number (UDI-DI Number): 6010 (20809160011253), 6010-1 (20809160011260), 6060 (20809160012090), 6070 (20809160011284), 6106 (20809160011314), 6141 (20809160011369), 6203 (20809160011741), 6805 (20809160011871), 6805-1 (20809160012069), 6810 (20809160012076), 6810-1 (20809160012083), 6830 (20809160012267), 6860 (20809160012564). All lots