BEUDAMED
    FDA Enforcement Class II Ongoing

    Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L Catalog Number: FG 12022. Intended adjunct in the estimation of blood loss.

    Recall: Z-1185-2023 · Reported March 8, 2023

    Enforcement

    Recall Number
    Z-1185-2023
    Event ID
    91578
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 8, 2023
    Initiation Date
    January 25, 2023
    Classification Date
    February 27, 2023
    Address
    1941 Stryker Way, N/A, Portage, MI, 49002-9711, United States

    Description

    Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L Catalog Number: FG 12022. Intended adjunct in the estimation of blood loss.

    Reason

    Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could potentially result in either delayed recognition or prolongation of postpartum hemorrhage (PPH), or require more aggressive treatment for PPH.

    Code Info

    UDI-DI: 10859506006101 Lot Numbers: M2112001, M2112003, M2202001, M2203001, M2204001, M2205001, M2206002

    Distribution

    US Nationwide distribution.

    Quantity

    541 units