BEUDAMED
    FDA Recall Terminated

    Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.

    Recall: Z-2433-2019 · Initiated July 22, 2019

    Recall

    Recall Number
    Z-2433-2019
    Event Number
    83468
    Firm
    GETINGE US SALES LLC
    FEI Number
    3012092534
    Product Code
    BSF
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 22, 2019
    Terminated
    May 26, 2020
    Address
    45 BARBOUR POND DR, WAYNE, NJ, 07470

    Description

    Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.

    Reason

    Reversed expiration and manufacturing date on the label

    Action

    Firm issued letter 7/22/2019. 1. Examine your inventory immediately to determine if you have a FLOWi DISPOSABLE CO2 ABSORBER with the product lot numbers 2. Affected product should be returned to Getinge 3. Please complete the Urgent Medical Device Recall Removal Response Form to acknowledge that you have received this Urgent Medical Device Recall Removal letter. 4. Please fax or email the completed form to Getinge office as instructed on the form. 5.Please contact Getinge Customer Service at 18886278383 (press option 2, then option 3) Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone), to request a return authorization (RMA) and shipping instructions to return any affected product. If you have any questions, please contact Getinge representative or call the Getinge Customer Support at +1 8886278383 (press option 2, then option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).

    Distribution

    US nationwide distribution.

    Quantity

    1444 boxes worldwide