Events

Recall of Device Recall SET UP PACK Surgical Instrument Tray

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    75746
  • Event Risk Class
    Class 2
  • Event Number
    Z-0896-2017
  • Event Initiated Date
    2016-11-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151130
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Tray, surgical, instrument - Product Code FSM
  • 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.

Device

Device Recall SET UP PACK Surgical Instrument Tray
  • Model / Serial
    Lot Number 1530330, Exp. Date November 2017;  Lot Number 1530241, Exp. Date September 2017;  Lot Number 1530095, Exp. Date September 2017;  Lot Number 1431734, Exp. Date August 2017;  Lot Number 1431066, Exp. Date May 2017
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    PA, FL, VA
  • Product Description
    SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE, Rx Only --- busse Hospital Disposables Hauppauge, NY --- Device Listing # A343147
  • Manufacturer
    Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables

Manufacturer

Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
  • Manufacturer Address
    Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables, 75 Arkay Dr, Hauppauge NY 11788-3707
  • Manufacturer Parent Company (2017)
    Robert Busse & Co. Inc.
  • Source
    USFDA