BEUDAMED
    FDA Recall Terminated

    Sterile Co-Flex Med 3" - Product Usage: Single Use secondary wound dressing or compression wrap

    Recall: Z-0183-2020 · Initiated June 19, 2019

    Recall

    Recall Number
    Z-0183-2020
    Event Number
    83239
    Firm
    Andover Healthcare Inc.
    FEI Number
    1220799
    Product Code
    FQM
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    June 19, 2019
    Terminated
    September 9, 2020
    Address
    9 Fanaras Dr, Salisbury, MA, 01952-1444

    Description

    Sterile Co-Flex Med 3" - Product Usage: Single Use secondary wound dressing or compression wrap

    Reason

    Incomplete packaging seal of sterile product

    Action

    1. Identify and return all 3" and 4" sterile CoFlex products (Nl, LF2, AFD, MED) made between October 1, 2018 and June 14, 2019. 2. Discontinue the distribution and use of all 3" and 4" sterile Coflex product (Nl, LF2, AFD, MED) 3. Fax, phone, or email the acknowledgement of this recall notice to Fax: 978-499-0826, Email: [email protected], Phone:1(800)432-6686 For further information, questions, or concerns reach out to Andover Healthcare at: Phone: 1 (800) 432-6686, Monday through Friday 8 AM to 4:30 PM Eastern Time.

    Distribution

    US Nationwide distribution including the states of MA, TX, RI, OH, NY, MN, SD, IL, MO, FL, VA, NE, UT, CA

    Quantity

    269 Cases