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

Hazard

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.

Details from the source

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. Quantity: 5,981,534 units 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

UPC codes

20809160011253, 20809160011260, 20809160012090, 20809160011284, 20809160011314, 20809160011369, 20809160011741, 20809160011871, 20809160012069, 20809160012076, 20809160012083, 20809160012267, 20809160012564

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.