BEUDAMED
    FDA Recall Terminated

    Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette, 5mm x 33cm Composite Probe, Double Spike, Ref ASC1201, packaged 1/box, 12 boxes/case, single use, RX, Sterile.

    Recall: Z-2487-2018 · Initiated June 11, 2018

    Recall

    Recall Number
    Z-2487-2018
    Event Number
    80288
    Firm
    Cardinal Health 200, LLC
    FEI Number
    3001236905
    Product Code
    GBX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 11, 2018
    Terminated
    August 17, 2020
    Address
    3651 Birchwood Dr, Waukegan, IL, 60085-8337

    Description

    Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette, 5mm x 33cm Composite Probe, Double Spike, Ref ASC1201, packaged 1/box, 12 boxes/case, single use, RX, Sterile.

    Reason

    The suction valve may not close properly which could cause continuous suction.

    Action

    The recalling firm issued letters dated 6/11/2018 via FedEx Next Day Priority Mail requesting return of the product.

    Distribution

    Distribution was made to AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, and WY. Government and military distribution was also made. Foreign distribution was made to Belgium, France, Germany, Israel, Italy, Netherlands, Singapore, and United Kingdom.

    Quantity

    A total of 63,020 valves were distributed. Specific product quantities were not provided.