BEUDAMED
    FDA Enforcement Class II Terminated

    Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label (component part number 11032). A software application used to help estimation of blood loss. Used with blood bearing canisters and accessories.

    Recall: Z-1402-2022 · Reported July 27, 2022

    Enforcement

    Recall Number
    Z-1402-2022
    Event ID
    90464
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Instruments Div. of Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 27, 2022
    Initiation Date
    January 22, 2020
    Classification Date
    July 19, 2022
    Termination Date
    January 29, 2024
    Address
    4100 E Milham Ave, N/A, Portage, MI, 49002-9704, United States

    Description

    Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label (component part number 11032). A software application used to help estimation of blood loss. Used with blood bearing canisters and accessories.

    Reason

    Some Canister Scanning Labels used to calibrate the Triton Canister System have a color variance. Based on a comprehensive analysis, blood loss estimates obtained using these Canister Scanning Labels may result in lower than expected results.

    Code Info

    UDI-DI GTIN: 10859506006101, 10859506006125 All Canister Scanning Labels with a date of manufacture prior to to 2019-12-24

    Distribution

    US Nationwide

    Quantity

    16,700 units