BEUDAMED
    FDA Recall Terminated

    Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx.

    Recall: Z-1884-2021 · Initiated April 29, 2021

    Recall

    Recall Number
    Z-1884-2021
    Event Number
    87915
    Firm
    Medtronic Perfusion Systems
    FEI Number
    1000116158
    Product Code
    DWF
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 29, 2021
    Terminated
    March 20, 2023
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088

    Description

    Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx.

    Reason

    Specific lots may have been manufactured with insufficient or incomplete welds.

    Action

    Medtronic notified customers by letters dated April 202, via 2-day UPS delivery to consignees explaining the reason for recall and requesting they immediately identify and quarantine all unused product in their inventory. The product was to be returned. A Customer Confirmation Certificate was enclosed for completion via scan and email. If product was further distributed or transferred, the consignee was requested to notify those downstream customers or facilities of the recall. For questions regarding this notification, customers were instructed to contact Smiths Medical via email at [email protected].

    Distribution

    US Nationwide Distribution in the states of AL, AZ, CA, IN, KY, MA, OH, TN, and TX. There was no foreign/government/military distribution.

    Quantity

    1 tubing pack