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U.S. Department of Health and Human Services

Class 2 Device Recall Medical Action Industries Inc.

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  Class 2 Device Recall Medical Action Industries Inc. see related information
Date Initiated by Firm October 12, 2022
Date Posted December 22, 2022
Recall Status1 Open3, Classified
Recall Number Z-0765-2023
Recall Event ID 91066
Product Classification Instrument, surgical, disposable - Product Code KDC
Product Medical Action Industries Inc. Disposable Instrument Pack, Littauer Scissor, REF 56247, packaged 1/package, 20 packages/box, 12 boxes/case, sterile.
Code Information Lot #297668, UDI 10809160003473.
Recalling Firm/
Manufacturer		 Medical Action Industries, Inc. 306
25 Heywood Rd
Arden NC 28704-9302
Manufacturer Reason
for Recall		 Scissors contained debris.
FDA Determined
Cause 2		 Under Investigation by firm
Action The recalling firm issued letters dated 10/12/2022 via email on 10/12/2022. The letter identified the affected product, the reason for recall, and requested the consignee review their inventory and segregate and quarantine all affected product. If any of the product is found, the consignee is to discard it. If the product was further distributed, the consignee is to ensure all end users are appropriately notified of the field correction. A Field Action response Form was to be completed and returned via email as soon as possible to indicate they have read and understand the recall instructions, checked their stock and reported the quantity of product on hand, and notified their appropriate staff of any customers of the notification.
Quantity in Commerce 145 cases (240 scissors/case)
Distribution Distribution was made to FL, IL, IN, MA, MD, MO, OH, and VA. There was no foreign/government/military distribution.
Total Product Life Cycle TPLC 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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