BEUDAMED
    FDA Enforcement Class II Terminated

    BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # E193298.

    Recall: Z-0895-2017 · Reported December 28, 2016

    Enforcement

    Recall Number
    Z-0895-2017
    Event ID
    75746
    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
    December 28, 2016
    Initiation Date
    November 15, 2016
    Classification Date
    December 22, 2016
    Termination Date
    June 21, 2018
    Address
    75 Arkay Dr, N/A, Hauppauge, NY, 11788-3707, United States

    Description

    BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # E193298.

    Reason

    Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated the affected gloves in several kits and distributed them prior to receipt of the recall notification.

    Code Info

    Lot Number 1230323, Exp. Date December 2016; Lot Number 1230387, Exp. Date December 2016; Lot Number 1231616, Exp. Date December 2016

    Distribution

    PA, FL, VA

    Quantity

    US: 35 cases