BEUDAMED
    FDA Enforcement Class II Ongoing

    HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology.

    Recall: Z-0939-2023 · Reported January 18, 2023

    Enforcement

    Recall Number
    Z-0939-2023
    Event ID
    91350
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stradis Healthcare
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 18, 2023
    Initiation Date
    December 15, 2022
    Classification Date
    January 11, 2023
    Address
    3600 Burwood Dr, Waukegan, IL, 60085-8399, United States

    Description

    HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology.

    Reason

    Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

    Code Info

    Assembly Number HCT3916-1, UDI-DI: M752HCT391611, Lot Numbers: 222491279, 220113056, 222782510, 221306003, 220051819, 222149971, 222210292, 221245035, 221458554

    Distribution

    US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

    Quantity

    76,260 units