BEUDAMED
    FDA Recall 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 · Initiated November 15, 2016

    Recall

    Recall Number
    Z-0895-2017
    Event Number
    75746
    Firm
    Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
    FEI Number
    2433012
    Product Code
    FCH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 15, 2016
    Terminated
    June 21, 2018
    Address
    75 Arkay Dr, Hauppauge, NY, 11788-3707

    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.

    Action

    Busse Hospital Disposables sent a Medical Device Correction letter (dated November 11, 2016) and response form to the three customers via FedEx on 11/15/2016 to inform them of the recall of the kits containing the affected gloves. This was done without notifying NYK-DO.

    Distribution

    PA, FL, VA

    Quantity

    US: 35 cases