Medical Action Industries recalls foam protective pouches with incorrect GMDN codes due to mislabeled UDI. Affected models include 6010, 6010-1, 6060, and others. No immediate action required as the hazard is a labeling error.
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.
Medical Action Industries is recalling foam protective pouches with model numbers 6010, 6010-1, 6060, and others because they have improper UDI labeling that causes misclassification of the medical device. This labeling error means the pouches might be used incorrectly in medical settings, but the recall does not require immediate action.
The protective pouches have incorrect Global Medical Device Nomenclature (GMDN) codes due to mislabeled Unique Device Identification (UDI) numbers. This misclassification could lead to improper use in medical settings, but the hazard is not a physical defect that causes injury.
Medical facilities and healthcare providers who use these foam protective pouches for medical devices. The risk is low as the hazard is a labeling error, not a physical defect.
Check for model numbers 6010, 6010-1, 6060, 6070, 6106, 6141, 6203, 6805, 6805-1, 6810, 6810-1, 6830, or 6860 on the pouches. All lots of these models are affected.
Look for model numbers 6010, 6010-1, 6060, 6070, 6106, 6141, 6203, 6805, 6805-1, 6810, 6810-1, 6830, or 6860 on the pouches.
The protective pouches have improper UDI labeling that causes misclassification of the Global Medical Device Nomenclature (GMDN) code, which could lead to incorrect use in medical settings.
No immediate action is required. The recall is for labeling correction, not a physical defect that causes injury.
Check the model numbers on the pouches. If they match the affected models listed, you do not need to take any action as the hazard is low risk.
We’ve drafted a message you can send Medical Action Industries to request your refund or repair — edit it as you like.
Subject: Recall Z-3129-2024 — Medical Action Industries Medical Action Industries Hello, I own a Medical Action Industries that is covered by recall Z-3129-2024 from Medical Action Industries. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
