BEUDAMED
    FDA Enforcement Class II Terminated

    Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle, Catalog # 977 Product Usage: Surgical procedure

    Recall: Z-0541-2018 · Reported February 14, 2018

    Enforcement

    Recall Number
    Z-0541-2018
    Event ID
    78950
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 14, 2018
    Initiation Date
    June 27, 2017
    Classification Date
    February 6, 2018
    Termination Date
    July 27, 2020
    Address
    75 Arkay Dr, N/A, Hauppauge, NY, 11788-3707, United States

    Description

    Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle, Catalog # 977 Product Usage: Surgical procedure

    Reason

    BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.

    Code Info

    Lot Numbers/Expiration Dates: 1) 1610197/Expiration Date: 12/01/2018; 2) 1610277/Expiration Date: 03/01/2019

    Distribution

    US Nationwide Distribution

    Quantity

    28 cases