BEUDAMED
    FDA Recall Terminated

    PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator; High pressure units (HPU) (40L and 45L). Model Numbers: 620-040-610, 620-040-611, 620-040-613, 620-040-614, 620-040-600, 620-040-601, 620-040-602, 620-040-604, 105-210-684 The Pneumo Sure XL High Flow Insufflator is a device that serves to create a cavity by insufflating CO2 during diagnostics and/or therapeutic laparoscopy. The insufflator consists of a console, that is intended to be connected to a CO2 gas source, and has a tubeset inserted to transport CO2 gas from the insufflator to the connecting trocar.

    Recall: Z-1566-2016 · Initiated March 28, 2016

    Recall

    Recall Number
    Z-1566-2016
    Event Number
    73674
    Firm
    Stryker Endoscopy
    FEI Number
    2936485
    Product Code
    HIF
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 28, 2016
    Terminated
    December 14, 2016
    Address
    5900 Optical Ct, San Jose, CA, 95138-1400

    Description

    PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator; High pressure units (HPU) (40L and 45L). Model Numbers: 620-040-610, 620-040-611, 620-040-613, 620-040-614, 620-040-600, 620-040-601, 620-040-602, 620-040-604, 105-210-684 The Pneumo Sure XL High Flow Insufflator is a device that serves to create a cavity by insufflating CO2 during diagnostics and/or therapeutic laparoscopy. The insufflator consists of a console, that is intended to be connected to a CO2 gas source, and has a tubeset inserted to transport CO2 gas from the insufflator to the connecting trocar.

    Reason

    When operating the device in high flow mode (40L/min, 15 mmHg) and connecting to a house gas inlet source, within seconds of insufflating the flow rate would drop to 0L/min and the red Check Gas Supply symbol would appear on the display, immediately suspending insufflation.

    Action

    Urgent Medical Device Recall letters were sent to domestic customers on March 28, 2016 by certified mail. Stryker International distribution sites were notified and are responsible for providing information to affected customers.

    Distribution

    Worldwide distribution. US nationwide including Puerto Rico, China, Hong Kong, India, Japan, Korea, Romania, Vietnam, Singapore, Taiwan, Netherlands, Peru, Australia, Canada, Mexico, Argentina, Chile, Poland, South Africa, and Guatemala.

    Quantity

    489