BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0179-2020 · Reported October 30, 2019

    Enforcement

    Recall Number
    Z-0179-2020
    Event ID
    83239
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Andover Healthcare Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 30, 2019
    Initiation Date
    June 19, 2019
    Classification Date
    October 23, 2019
    Termination Date
    September 9, 2020
    Address
    9 Fanaras Dr, Salisbury, MA, 01952-1444, United States

    Description

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

    Reason

    Incomplete packaging seal of sterile product

    Code Info

    Manufacturer's product or Catalog # 5300S Expiration Date: 01OCT2021-14JUN2022 Lot # CI0ST7, CI0ZJT, CI17BA, CI18Y6, CI1HM0

    Distribution

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

    Quantity

    1798 Cases