BEUDAMED
    FDA Recall Terminated

    Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100

    Recall: Z-1937-2015 · Initiated May 7, 2015

    Recall

    Recall Number
    Z-1937-2015
    Event Number
    71023
    Firm
    Atrium Medical Corporation
    FEI Number
    3011175548
    Product Code
    PAD
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 7, 2015
    Posted
    June 29, 2015
    Terminated
    April 26, 2016
    Address
    5 Wentworth Dr, Hudson, NH, 03051-4929

    Description

    Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100

    Reason

    Chest drains have a missing o-ring

    Action

    Atrium Medical issued recall letter dated 5/7/15 to inform customers of the steps to take should they encounter affected product. If the O-ring is not present on the patient tubing: a. Do not use the chest drain. b. Replace the entire chest drain including the patient tubing. Open up another chest drain package and repeat steps 1 to 3. c. Return any units with missing O-rings to Atrium. If the O-ring is present then reconnect in-line connector and proceed with set up as normal. Complete and return Field Action Reply Form to the following e-mail address: [email protected] or you may fax it to 1-603-386-6590. If you have any questions, please contact your local Atrium/Maquet chest drainage representative or Atrium Customer Service at 1-800-528-7486 (603-880-1433), Monday through Friday between 8:00 am and 5:00 pm (EST).

    Distribution

    Nationwide Canada, Germany

    Quantity

    1170 cases