Events

Recall of Device Recall BD 60 ml Syringe LuerLok Tip

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
    49015
  • Event Risk Class
    Class 2
  • Event Number
    Z-2374-2008
  • Event Initiated Date
    2008-07-15
  • Event Date Posted
    2008-09-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-04-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72525
  • 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 FMF
  • Reason
    Becton dickinson identified the presence of open seals during an internal inspection process.
  • Action
    Urgent: Product Recall letters were sent to Distributors and Syringe Customers on July 15, 2008 by UPS second day air. Customers are to immediately review their inventory, determine if they have any affected product, and remove the affected if they have any. Next customers should complete the enclosed Customer Packing List and BD will send a replacement product upon receipt of the returned product. Questions are to be directed to BD Customer Service at 1-888-237-2762, M-F, 8:00 AM to 5:00 PM EST.

Device

Device Recall BD 60 ml Syringe LuerLok Tip
  • Model / Serial
    Reorder Number: 309653; Lot numbers beginning with the numbers 5, 6, or 7 and also the following lot numbers. 8010954, 8014571, 8031115, 8031117, 8031119, 8031124, 8031133, 8038154, 8038158, 8045564, 8045567, 8058890, 8058896, 8058898, 8058900, 8058902, 8072401, 8072409, 8072414, 8072419, 8079645, and 8079656.  Note: In order to make the recall practical for customers to implement, BD has requested the return of lots beginning with the numbers 5,6 or 7. while not all lots beginning with the digits 5,6 and 7 exhibit the issue, it is much easier to instruct customers to return these lots, rather than have customrs examine/check a more comprehensive list of affected and unaffected lots.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    BD 60 ml Syringe, Luer-Lok Tip || Sterile; || Cases : 160 (4 x 40) || Shelf Carton: 40 || BD; Franklin Lakes, NJ 07417 USA. 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