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Terminated

Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF

FDA Recall Z-1549-2022 · Posted None

Recalling FirmTrinity Sterile, Inc.
Recall StatusTerminated
Product CodeOXQ
Date Initiated2022-06-29
Date Terminated2024-05-10
Product Quantity1,513 cases (45,390 eaches)

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

Firm Action

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 [email protected]. 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.

Root Cause

Labeling design

Distribution Pattern

US Nationwide distribution in the states of FL, PA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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