BEUDAMED
    FDA Recall Terminated

    Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF

    Recall: Z-1551-2022 · Initiated June 29, 2022

    Recall

    Recall Number
    Z-1551-2022
    Event Number
    90625
    Firm
    Trinity Sterile, Inc.
    FEI Number
    1000123297
    Product Code
    OXQ
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    June 29, 2022
    Terminated
    May 10, 2024
    Address
    201 Kiley Dr, Salisbury, MD, 21801-2249

    Description

    Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF

    Reason

    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

    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.

    Distribution

    US Nationwide distribution in the states of FL, PA.

    Quantity

    4,169 cases (125,070 eaches)