BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1551-2022 · Reported August 24, 2022

    Enforcement

    Recall Number
    Z-1551-2022
    Event ID
    90625
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Trinity Sterile, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 24, 2022
    Initiation Date
    June 29, 2022
    Classification Date
    August 18, 2022
    Termination Date
    May 10, 2024
    Address
    201 Kiley Dr, Salisbury, MD, 21801-2249, United States

    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

    Code Info

    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

    Distribution

    US Nationwide distribution in the states of FL, PA.

    Quantity

    4,169 cases (125,070 eaches)