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U.S. Department of Health and Human Services

Class 2 Device Recall Foam Protective Pouches

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 Class 2 Device Recall Foam Protective Pouchessee related information
Date Initiated by FirmJune 11, 2024
Date PostedSeptember 12, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3129-2024
Recall Event ID 95157
Product Classification Tray, surgical, instrument - Product Code FSM
ProductFoam 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)
Code Information 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
Recalling Firm/
Manufacturer		 Medical Action Industries, Inc. 306
25 Heywood Rd
Arden NC 28704-9302
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionMedical Action Industries notified consignees on 06/11/2024 via mail and email. Consignees were instructed to identify and quarantine any affected units in inventory, destroy all affected product, notify any customers if product was further distributed, and to complete and return the response form.
Quantity in Commerce5,981,534 units
DistributionNationwide distribution. International distribution to Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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