BEUDAMED
    FDA Enforcement Class II Terminated

    Stereo Breast Biopsy Tray Catalog Number: 2383R1

    Recall: Z-1165-2022 · Reported June 8, 2022

    Enforcement

    Recall Number
    Z-1165-2022
    Event ID
    90072
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Busse Hospital Disposables, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 8, 2022
    Initiation Date
    February 22, 2022
    Classification Date
    May 28, 2022
    Termination Date
    April 17, 2024
    Address
    75 Arkay Dr, N/A, Hauppauge, NY, 11788-3707, United States

    Description

    Stereo Breast Biopsy Tray Catalog Number: 2383R1

    Reason

    Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

    Code Info

    Lot Numbers: 2130565 UDI: 00849233004344

    Distribution

    Nationwide

    Quantity

    23 units