BEUDAMED
    FDA Enforcement Class II Terminated

    Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for aspiration or injection of medication or enteral feeding solution from inverted multi-dose vials.

    Recall: Z-0727-2022 · Reported March 16, 2022

    Enforcement

    Recall Number
    Z-0727-2022
    Event ID
    89487
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    B. Braun Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 16, 2022
    Initiation Date
    January 31, 2022
    Classification Date
    March 7, 2022
    Termination Date
    April 29, 2024
    Address
    901 Marcon Blvd, N/A, Allentown, PA, 18109-9512, United States

    Description

    Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for aspiration or injection of medication or enteral feeding solution from inverted multi-dose vials.

    Reason

    This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of the Air-Inlet Filter may increase the risk of decreasing the dose of medication delivered to the patient, cause delays in treatment due to the need to replace the device or may cause contamination of the fluid path that can lead to bloodstream infection.

    Code Info

    Product Code 412005 Lot Number 0061788969 Expiration date 5/31/2026 GUDID 04022495769633

    Distribution

    US Nationwide distribution in the states of AZ, CA, FL, LA, MI, MO, MS, NC, NJ, OH, PA, TN, TX, and UT. The country of Canada.

    Quantity

    15,550 ea (US); 900 ea (OUS)