Foam Protective Pouches, model numbers 6010 (50 each/case), 6010-1 (350 each /case), 6060 (8 rolls/case), 6070 (75 each/
Summary
The FDA issued a Class II for Foam Protective Pouches, model numbers 6010 (50 each/case), 6010-1 (350 each /ca by Medical Action Industries, Inc. 306. Reason: The protective pouches were identified to have been improperly labeled with UDI that is associated with an incorrect GMDN (Global Medical Device Nomen.
Details
Source
Device Recall
External ID
Z-3129-2024
Action Date
2024-09-18
Status
Ongoing
Category
device
Product Description
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)
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
Quantity Affected: 5,981,534 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-11
Company
Arden, NC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 257 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medical Action Industries, Inc. 306 has 8 FDA actions in our database, including 8 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medical Action Industries, Inc. 306) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medical Action Industries, Inc. 306 have FDA actions?
Medical Action Industries, Inc. 306 has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3129-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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