Events

Recall of VACUTAINER Brand Push Button Blood Collection Sets.

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
    28164
  • Event Risk Class
    Class 2
  • Event Number
    Z-0549-04
  • Event Initiated Date
    2003-12-17
  • Event Date Posted
    2004-02-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-03-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31303
  • 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
    Tubes, Vials, Systems, Serum Separators, Blood Collection - Product Code JKA
  • Reason
    A hole was noticed in the 'blister pack' that is used to package the device and provides the sterility barrier. sterility could be compromised.
  • Action
    BD Sales Organization directly contacted all customers with return instructions on December 22, 2003. All consignees responded.

Device

VACUTAINER Brand Push Button Blood Collection Sets.
  • Model / Serial
    Batch # 3218665
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The firm was able to determine that the product was distributed to 3 customers: Long Beach Memorial, Long Beach, CA; Potomac Hospital, Woodbridge Prince William, VA; and St. Joseph Hospital, Orange, CA.
  • Product Description
    VACUTAINER Brand Push Button Blood Collection Sets.
  • 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