FDA recall Z-3129-2024

Medical Action Industries, Inc. 306 · Class II · device

Product

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

Nationwide distribution. International distribution to Canada.

Key facts

Status
Ongoing
Initiation date
2024-06-11
Report date
2024-09-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Arden, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3129-2024