BEUDAMED
    FDA Recall Open, Classified

    Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE

    Recall: Z-0594-2024 · Initiated November 30, 2023

    Recall

    Recall Number
    Z-0594-2024
    Event Number
    93546
    Firm
    Busse Hospital Disposables, Inc.
    FEI Number
    2433012
    Product Code
    NXA
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 30, 2023
    Posted
    January 3, 2024
    Address
    75 Arkay Dr, Hauppauge, NY, 11788-3707

    Description

    Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE

    Reason

    Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed. Risks to patients if product is used include blood stream infections, urinary tract infections, or respiratory infections; in the worst-case scenario, there is risk of sepsis or death.

    Action

    On November 21, 2023, the firm notified affected distributors via URGENT MEDICAL DEVICE RECALL letters. Customers were asked to segregate and destroy any affected kits. Distributors should also inform their customers of the recall. Customers should return any affected product to their distributor. For questions, email [email protected]

    Distribution

    US Nationwide distribution.

    Quantity

    240