BEUDAMED
    FDA Enforcement Class II Terminated

    STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: a. Stryker AHTO Tube Set Packaging (Model 0250070600); b. Stryker AHTO Tube Set with Tip Packaging (Model 0250070620);

    Recall: Z-0836-2018 · Reported March 14, 2018

    Enforcement

    Recall Number
    Z-0836-2018
    Event ID
    78668
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 14, 2018
    Initiation Date
    November 17, 2017
    Classification Date
    March 2, 2018
    Termination Date
    January 29, 2024
    Address
    5900 Optical Ct, N/A, San Jose, CA, 95138-1400, United States

    Description

    STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: a. Stryker AHTO Tube Set Packaging (Model 0250070600); b. Stryker AHTO Tube Set with Tip Packaging (Model 0250070620);

    Reason

    Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.

    Code Info

    a. Model 0250070600, UDI 07613327061499, Lot No. 17284FG2, 17291FG2, 17300FG2; b. Model 0250070620, UDI 07613327061659, Lot No. 17275FG2, 17279FG2, 17280FG2, 17282FG2, 17283FG2, 17284FG2, 17285FG2, 17286FG2, 17289FG2, 17291FG2, 17292FG2, 17293FG2, 17297FG2, 17298FG2, 17299FG2;

    Distribution

    Distributed domestically to . Distributed internationally to Australia and Mexico.

    Quantity

    60,753 units total