Events

Recall of Device Recall Vacutainer

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
    34204
  • Event Risk Class
    Class 2
  • Event Number
    Z-0372-06
  • Event Initiated Date
    2005-12-01
  • Event Date Posted
    2006-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-04-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43269
  • 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
    Container, Empty, For Collection & Processing Of Blood & Blood Components - Product Code KSR
  • Reason
    Cracked finger grip luer adapter components on the push button blood collection set.
  • Action
    Recall notification was sent out to the customers on 12/5/2005.

Device

Device Recall Vacutainer
  • Model / Serial
    Catalog # -- Lot #:  367352 -- 5188576; 367352 -- 5208448; 367352 -- 5217290; 368656 -- 5164491; 368656 -- 5164526; 368656 -- 5187894; 368656 -- 5192496; 368656 -- 5220204; 368656 -- 5238936.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The device was shipped to 23 wholesalers, 5 hospitals, and 1 VA govt. account nationwide.
  • Product Description
    BD Vacutainer Push Button Blood Collection Set with Pre-Attached holder.
  • 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