Events

Recall of Device Recall Henry Schein

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Becton Dickinson & Company.

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
    73828
  • Event Risk Class
    Class 2
  • Event Number
    Z-1936-2016
  • Event Initiated Date
    2016-03-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145062
  • 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
    Syringe, piston - Product Code FMF
  • Reason
    Bd 10 ml syringe luer-lok tip with bd precisionglide needle 21g x 1 (0.8 mm x 25 mm) and henry schein 10 ml single use syringe luer-lock are being recalled due to possible adulteration and non-conforming manufacturing practices.
  • Action
    Becton Dickinson sent via email and UPS Ground an "Urgent Voluntary Product Recall" Letter dated March 25, 2016 along with a Recall Response Form and packaging instructions to their sole customer. Customers were instructed to immediately review their inventory , quarantine any affected product, and immediately discontinue shipment of the affected product. Customers should complete the Recall Response Card from and fax it to BD at 1-201-847-6990. Return all affected product with the completed Recall Response Card. If product was further distributed please identify your customers and notify them immediately of the product recall. Customers were also instructed to complete the Recall Response Form even if they do not have any affected lots in their inventory. Customers with questions were instructed to call 1-201-847-4267. For questions regarding this recall call 201-847-5612.

Device

Device Recall Henry Schein
  • Model / Serial
    Catalog (REF #) 9004476, Lot #4163707
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to NY only
  • Product Description
    Henry Schein Single Use Syringe Luer-Lock, 10 mL, || Intended for use by health care professionals for general purpose fluid aspiration/injection
  • Manufacturer
    Becton Dickinson & Company

Manufacturer

Becton Dickinson & Company
  • Manufacturer Address
    Becton Dickinson & Company, 1 Becton Dr, Franklin Lakes NJ 07417-1815
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA