Wolf Pak Premium Dressing Change Kit with GuardVA and recall: Labeling Error
Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF
Why was Wolf Pak Premium Dressing Change Kit with GuardVA and recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF
- Recalling firm
- Trinity Sterile, Inc.
- Quantity
- 4,169 cases (125,070 eaches)
- Distribution
- US Nationwide distribution in the states of FL, PA.
- Recall date
- August 24, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)