Events

Recall of Device Recall SafetyLok Blood Collection Set

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
    37710
  • Event Risk Class
    Class 2
  • Event Number
    Z-0777-2007
  • Event Initiated Date
    2007-03-20
  • Event Date Posted
    2007-05-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-07-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51364
  • 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
    Blood Collection Set - Product Code JKA
  • Reason
    The bd vacutainer safety-lok blood collection set with preattached holder has a problem where the non-patient needle (in the holder) may become separated from the hub and remain the stopper of an evacuated blood collection tube.
  • Action
    Recall letters were sent to customers on 3/11/2007 via a third party, West Inc., Appleton, WI who will coordinate the mailing to all consignees.

Device

Device Recall SafetyLok Blood Collection Set
  • Model / Serial
    Catalog # 368652 Lot Numbers: 5236082; 5236093; 5236095.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada.
  • Product Description
    BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder. Color green. 21 Gauge. Translucent, integrated protective shield that provides one-handed activation immediately after use, 0.75 in needle length, 12 in tubing, Luer adapter and holder, wings, sterile.
  • 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