Events

Recall of Device Recall BD Precision Glide Needle

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
    77639
  • Event Risk Class
    Class 2
  • Event Number
    Z-0207-2018
  • Event Initiated Date
    2017-05-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157016
  • 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
    Needle, hypodermic, single lumen - Product Code FMI
  • Reason
    Hub damage resulting in breakage and/or leakage during use.
  • Action
    On May 31, 2017 BD distributed Urgent Medical Device Recall notices and Business Response Cards to their customers. Customers were advised to immediately review their inventory for the specific Catalog (Ref) and lot number, discontinue use of and quarantine the affected item. Complete and return the Business Response Card form via fax to BD 855-544-4803 or email the form to bd4354@stericycle.com. Return all affected products with the completed Business Response Card form following the instruction on the enclosed packing instruction. Upon receipt of the returned product, BD will issue product replacement. Note: If customers do not have any of the affected lots in your inventory, please complete the Business Response Card form indicating you have zero (0) quantity. Customers who have questions or require further assistance with the return of the recalled product, please contact 855-215-4932 between 8AM and 5PM, EST, Monday through Friday.

Device

Device Recall BD Precision Glide Needle
  • Model / Serial
    Lot Number: 6152995 Expiration Date: 31-Jul-21
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    BD Precision Glide Needle 18G x 1 RB, Catalog 305195 || Product Usage: || These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain blood collection and insulin 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