Events

Recall of Device Recall BD 1 ml Integra TB Syringe

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
    50235
  • Event Risk Class
    Class 3
  • Event Number
    Z-0619-2009
  • Event Initiated Date
    2008-11-24
  • Event Date Posted
    2009-01-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-03-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75048
  • 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 - Product Code MEG
  • Reason
    Expiry date on the shelf carton is incorrect. it reads 2013-13, it should read 2013-03.
  • Action
    Recall letters were sent on November 24, 2008 to all direct customers and potential end users of the product by UPS second day air. BD requests that inventory be examined and affected product be quarantined and returned as per recall letter instructions. Questions should be directed to BD customer service at 888-237-2762, M-F 8.OO AM to 5:00 PM EST.

Device

Device Recall BD 1 ml Integra TB Syringe
  • Model / Serial
    Lot number 8078251
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    GA, KS, OH, MO, FL, PA, KY and NY.
  • Product Description
    BD 1 ml Integra TB Syringe with Retracting Precision Glide Needle; 1 ml 27 g 1/2 (0.4mm x 13 mm); Sterile; REF # 305298 || BD, Franklin Lakes, NJ 07417. Made in USA || Syringes 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