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)
- Company
- Medical Action Industries Inc
- Recall Initiated
- June 11, 2024
- Posted
- September 12, 2024
- Recall Number
- Z-3129-2024
- Quantity
- 5,981,534 units
- Firm Location
- Arden, NC
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
Nationwide distribution. International distribution to Canada.
Lot / Code Info
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
Root Cause
Under Investigation by firm
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.