Reported Sep 18, 2024 · Ongoing
Foam Protective Pouches, model numbers 6010 (50 each/case), 6010-1 (350 each /case), 6060 (8 rolls/case), 6070 (75…
Medical Action Industries, Inc. 306
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medical Action Industries, Inc. 306 · 25 Heywood Rd · Arden, NC · 28704-9302
Is this the product you have?
Foam Protective Pouchesmodel 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)
- Lot codes and dates
- 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
- Model Number (UDI-DI Number)
- Amount recalled
- 5,981,534 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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