BEUDAMED
    FDA Recall Terminated

    Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039

    Recall: Z-1603-2020 · Initiated February 20, 2020

    Recall

    Recall Number
    Z-1603-2020
    Event Number
    85104
    Firm
    Maquet Cardiovascular Us Sales, Llc
    FEI Number
    3008355164
    Product Code
    DRE
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 20, 2020
    Terminated
    January 18, 2022
    Address
    45 Barbour Pond Dr, Wayne, NJ, 07470-2094

    Description

    Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039

    Reason

    A lot of Avalon Elite Vascular Access Kits (VAK) are being recalled due to a material mix-up with the needle portion of the kit; 81 of 255 kits were assembled with an incorrect Arterial Access Needle instead of a Multi-Purpose Procedure Needle.

    Action

    On February 20, 2020, the recalling firm notified affected customers via Urgent Medical Device Recall letters sent through FedEx. Customers were informed of the material mix-up with the needle portion of the kit. Customers were instructed to immediately examine their inventory to determine if they have any of the affected lot. If so, please remove the kits from areas of use and return the product to Getinge following the instructions in the letter. Unused and unexpired affected product that is returned to Getinge is eligible for full credit.

    Distribution

    Domestic distribution only to the following states: AL AZ CA CT FL GA IL MA MI NC NH NM NY OH OK TN TX VA

    Quantity

    255