BEUDAMED
    FDA Recall Terminated

    Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.

    Recall: Z-1728-2019 · Initiated March 7, 2019

    Recall

    Recall Number
    Z-1728-2019
    Event Number
    82489
    Firm
    Stryker Corporation
    FEI Number
    2936485
    Product Code
    HIF
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 7, 2019
    Terminated
    March 8, 2024
    Address
    5900 Optical Ct, San Jose, CA, 95138-1400

    Description

    Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.

    Reason

    The heated tube sets were consistently leaking and detaching from the cassette.

    Action

    The recalling firm issued letters dated 3/7/2019 via certified mail on 3/7/2019. A second letter dated 3/7/2019 was issued on 4/15/2019 via certified mail to two customers which included an additional lot number for one of the products.

    Distribution

    Distribution was nationwide to medical facilities. There was government/military distribution. Foreign distribution was made to Argentina, Brazil, Canada, Chile, Colombia, (EMEA-no specific address/country listed), India, Japan, Latin America (no country listed), Mexico, Saudi Arabia, UAE, and Uruguay.

    Quantity

    19,083 boxes