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U.S. Department of Health and Human Services

Class 2 Device Recall Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok

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 Class 2 Device Recall Wolf Pak Premium Dressing Change Kit with GuardVA and Statloksee related information
Date Initiated by FirmJune 29, 2022
Create DateAugust 18, 2022
Recall Status1 Terminated 3 on May 10, 2024
Recall NumberZ-1551-2022
Recall Event ID 90625
Product Classification Dressing change tray - Product Code OXQ
ProductWolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF
Code Information UDI-DI: 10850007185722 Case 00850007185725 Kit Lot Numbers: 600000 600001 600002 600003 600004 600005 600008 600009 600010 600011 600012 600013 600014 600015 600017 600018 600019
FEI Number 1000123297
Recalling Firm/
Manufacturer		 Trinity Sterile, Inc.
201 Kiley Dr
Salisbury MD 21801-2249
For Additional Information ContactSAME
410-860-5123
Manufacturer Reason
for Recall		Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy
FDA Determined
Cause 2		Labeling design
ActionTrinity Medical issued Urgent Medical Device Correction Letter dated June 30, 2022 via email as a follow-up to the call on 6/29/22. Letter states reason for recall, health risk and action to take: 1. Inspect your inventory for the affected products and lot numbers identified on the attached spreadsheet. If you have affected stock in inventory, immediately discontinue use and quarantine the products. If you have transferred any of the affected kits to a third party, please communicate this information to them. 2. Notify Trinity. Please complete the enclosed Customer Response Form as soon as possible, indicating whether you understand this medical device correction. Fax it to 410-860-2913 or email it to customerservice@trinitysterile.com. 3. Relabel the affected product. Once Trinity receives your completed Customer Response Form, Trinity will provide you with brightly colored stickers to attach to each case and kit. If you have any questions, please contact Customer Service at 410-860-5123.
Quantity in Commerce4,169 cases (125,070 eaches)
DistributionUS Nationwide distribution in the states of FL, PA.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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