BEUDAMED
    FDA Recall Terminated

    MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1126

    Recall: Z-2152-2018 · Initiated May 24, 2018

    Recall

    Recall Number
    Z-2152-2018
    Event Number
    80201
    Firm
    Sun Med, LLC
    FEI Number
    1314417
    Product Code
    BTM
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    May 24, 2018
    Terminated
    May 12, 2020
    Address
    2710 Northridge Dr NW, Ste A, Grand Rapids, MI, 49544-9112

    Description

    MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1126

    Reason

    There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.

    Action

    On May 25, 2018 Sun Med, LLC issued URGENT MEDICAL DEVICE PRODUCT REMOVAL notices to two of their customers. On June 1, 2018 Sun Med, LLC issued a press release. Customers were encouraged to take the following actions: 1) Examine inventory, quarantine and cease distribution of impacted product. 2) If customers further distributed product, please identify your customers/consignees and notify them of this product removal. Your notification may be enhanced by including a copy of the removal notice. If you need any assistance contacting your customers, please inform SunMed. 3) Complete and return the Removal Return Response Form via fax to 1-800-400-8820 or via email to [email protected] as soon as possible. 4) Once you return the affected product(s), new corrected replacement resuscitation bags will be provided to you. If you need replacement products to be sent to you urgently, please call SunMed directly. Customers with questions can call 1-800-433-2797 or email [email protected]

    Distribution

    IL & OH distributors

    Quantity

    350 cases