BEUDAMED
    FDA Enforcement Class II Terminated

    PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a single use sterile tube set used in combination with the PNEUMOCLEAR C02 insufflator as a separate accessory. The device PNEUMOCLEAR is a C02 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard, High Flow/Bariatric, Pediatric and Advanced Flow operating mode of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is indicated for pediatric laparoscopic procedures. The Vessel Harvest operating mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery. The TAMIS operating mode is indicated to fill and distend the rectum and colon using C02 gas during trans anal minimal invasive surgery.

    Recall: Z-0508-2019 · Reported December 5, 2018

    Enforcement

    Recall Number
    Z-0508-2019
    Event ID
    81480
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    WOM World of Medicine AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 5, 2018
    Initiation Date
    October 22, 2018
    Classification Date
    November 27, 2018
    Termination Date
    May 6, 2021
    Address
    Salzufer 8, N/A, Berlin, N/A, N/A, Germany

    Description

    PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a single use sterile tube set used in combination with the PNEUMOCLEAR C02 insufflator as a separate accessory. The device PNEUMOCLEAR is a C02 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard, High Flow/Bariatric, Pediatric and Advanced Flow operating mode of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is indicated for pediatric laparoscopic procedures. The Vessel Harvest operating mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery. The TAMIS operating mode is indicated to fill and distend the rectum and colon using C02 gas during trans anal minimal invasive surgery.

    Reason

    It is possible that the packaging of the product can be damaged by the prongs on the tube set.

    Code Info

    Lots from 4011926 to 4013513 (ALL)

    Distribution

    Worldwide Distribution - US in the state of California and country of Netherlands

    Quantity

    124,180 tube sets