Trinity Sterile, Inc. Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

Trinity 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.