Events

Recall of Device Recall BD 30G1/2 PrecisionGlide 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
    56663
  • Event Risk Class
    Class 2
  • Event Number
    Z-0023-2011
  • Event Initiated Date
    2010-08-24
  • Event Date Posted
    2010-10-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94201
  • 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
    Image-Intensified Fluoroscopic X-Ray System. - Product Code GAA
  • Reason
    There have been reports of blocked/clogged needles for the 30 gauge precisionglide needles.
  • Action
    BD sent out Product Correction letters to all end users of the product on 8/24/10. Letters were mailed by BD via UPS second day air. The letter stated the issue and said that customers should assess the patency prior to injection. The letter also stated that a BD 30 gauge PrecisionGlide Needle from another lot can be used in place of a clogged needle. If customers require replacement needles or further assistance, they can contact BD at 1-888-237-2762. Finally, the letter states that BD has implemented corrective actions to reduce the potential for further recurrence of the blockage issue.

Device

Device Recall BD 30G1/2 PrecisionGlide Needle
  • Model / Serial
    Lot number 9057615
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA and Canada.
  • Product Description
    BD 30G1/2 PrecisionGlide¿ Needle;Catalog/Lot Number: 305106. || Needles are intended for use in aspiration and injection of medications.
  • 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