BEUDAMED
    FDA Recall Terminated

    3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.

    Recall: Z-0055-2013 · Initiated September 28, 2012

    Recall

    Recall Number
    Z-0055-2013
    Event Number
    63362
    Firm
    ICU Medical, Inc.
    FEI Number
    2025816
    Product Code
    DQO
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    September 28, 2012
    Posted
    October 11, 2012
    Terminated
    February 19, 2013
    Address
    951 Calle, Amanecer San Clemente, CA, 92673-6212

    Description

    3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.

    Reason

    ICU Medical, Inc. has identified a potential comingling of components where a 60 drop micro drip chamber may have been included on a 20 drop macro drip set.

    Action

    ICU Medical sent an "URGENT:MEDICAL DEVICE RECALL" letter dated September 28, 2012 to its customer. The letter identified the product, problem, and actions to be taken by the customer. The customer has been instructed to inspect their inventory for the specific lot numbers, examine for the presence of a metal cannula, and certify destruction of any affected devices. The customer letter included a Verification Form to be completed and returned. Contact ICU Customer Service Monday through Friday between the hours of 8:30 AM and 4:00 PM Pacific time: 866-829-9025 and select option 8, or e-mail the following address: [email protected]" for questions regarding this notice.

    Distribution

    Nationwide distribution: Virginia only.

    Quantity

    60