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U.S. Department of Health and Human Services

Class 2 Device Recall MEDLINE

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 Class 2 Device Recall MEDLINEsee related information
Date Initiated by FirmNovember 12, 2024
Date PostedDecember 23, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0755-2025
Recall Event ID 95843
Product Classification Scissors, general, surgical - Product Code LRW
ProductO.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000
Code Information UDI: 10193489191349 (ea) 20193489191346 (case); Lot 2023052490
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
Manufacturer Reason
for Recall		Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
FDA Determined
Cause 2		Process control
ActionOn November 25, 2024, the firm notified customers via letters titled IMMEDIATE ACTION REQUIRED. Customers were informed that specific items and lots of Pure Pouch Single-Sterile and Sterile Kits are being recalled due to weak seals. Affected product must be destroyed. The letter included instructions on actions to take to be issued a credit. Customers should immediately check their stock for affected product and quarantine all units. Affected lots should be destroyed. When the recalling firm has received your completed destruction form, your account will be issued a credit, if applicable. If you have any questions, please contact 866-359-1704.
Quantity in Commerce21,440 total
DistributionUS Nationwide distribution.
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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