BEUDAMED
    FDA Recall Terminated

    Combiset Blood Line with BVM for Hemodialysis use Catalog Number: 03-2965-9. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.

    Recall: Z-0185-2014 · Initiated August 29, 2013

    Recall

    Recall Number
    Z-0185-2014
    Event Number
    65739
    Firm
    Fresenius Medical Care Holdings, Inc.
    FEI Number
    3001451489
    Product Code
    ONW
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    August 29, 2013
    Posted
    November 8, 2013
    Terminated
    February 11, 2021
    Address
    920 Winter St, Waltham, MA, 02451-1521

    Description

    Combiset Blood Line with BVM for Hemodialysis use Catalog Number: 03-2965-9. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.

    Reason

    Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss

    Action

    Fresenius issued a Field Notification Letter dated 8/29/13 to Patient Clinics/ associated at home patients and provides additional detail instructions to ensure the connection to the transducer protector bloodline female luer interface is secure. This field advisory notice sent by Certified Mail, Return Receipt Requested. Accounts requested to return both the receipt and the completed reply form (enclosed) to confirm receipt of the notice. If you have any questions regarding this field advisory, please contact FMCNA Customer Service Team at 1-800-323-5188. Customer Service will be available Monday-Friday 7am-6pm CST.

    Distribution

    Worldwide Distribution-USA (nationwide) and the country of Canada.

    Quantity

    24,202 cases