Events

Recall of Device Recall SafetyDeluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle

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
    78950
  • Event Risk Class
    Class 2
  • Event Number
    Z-0541-2018
  • Event Initiated Date
    2017-06-27
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160950
  • 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
    Lumbar puncture tray (adult & pediatric) - Product Code PWY
  • Reason
    Bd safetyglide needle 22ga 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
  • Action
    On June 27, 2017, Busse Hospital Disposables distributed Urgent Medical Device Recall notices and Response Forms to their customers via courier service. A copy of the supplier's recall notice was also provided to customers. Customers were advised to conduct the following: " Discontinue use of needle immediately. " Please check your inventory and cease distribution immediately. " If you have distributed the above products, please contact your customers and inform them of this recall immediately. " Contact Busse Hospital Disposables for a Return Good Authorization number. " Complete and Return the Response Form via fax to 631-435-2849 or via email to: ijacobo@busseinc.com. Customers with questions may call 631-435-4711, ext. 254.

Device

Device Recall SafetyDeluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle

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