BEUDAMED
    FDA Recall Open, Classified

    Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss.

    Recall: Z-1186-2023 · Initiated January 25, 2023

    Recall

    Recall Number
    Z-1186-2023
    Event Number
    91578
    Firm
    Stryker Corporation
    FEI Number
    3015967359
    Product Code
    PBZ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    January 25, 2023
    Posted
    February 27, 2023
    Address
    1941 Stryker Way, Portage, MI, 49002-9711

    Description

    Triton Canister Software Catalog Number: GAUS-2. 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.

    Action

    Stryker issued Urgent Medical Device Correction letter to Risk Manager, OR Director, Materials Manager dated Jan 25, 2023. Letter states reason for recall, health risk and action to take: Steps: 1. Immediately check your internal inventory to locate any affected Finished Goods Inserts and Scanning labels (FG 12010 and FG 12022). Quarantine and discontinue use of all affected products. 2. A Stryker representative will contact your facility to assist updating the Triton Canister software. 3. Return the enclosed Business Reply Form (BRF) even if you don t have any affected product on hand, via email to [email protected]. 4. If the BRF indicates that recalled product is currently on hand, a shipping label will be provided to return recalled product. Upon receipt of the recalled product, Stryker will arrange replacements. 5. Maintain awareness of this communication internally until all required actions have been completed within your facility. Contact: Sylvia Page | Stryker Instruments Recall Coordinator 269-501-8375 |[email protected]

    Distribution

    US Nationwide distribution.

    Quantity

    88 units