Events

Recall of Device Recall BD Vacutainer Plastic Plasma Separator Tube (PST) Plus

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
    64013
  • Event Risk Class
    Class 3
  • Event Number
    Z-0911-2013
  • Event Initiated Date
    2012-03-05
  • Event Date Posted
    2013-03-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115217
  • 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
    Bd is conducting a recall of the bd vacutainer plus plastic plasma separator tube (pst) with light green/bd homogard closure due to a deformed top of the tube reservoir reported in two customer complaints.
  • Action
    BD sent advisory letters via UPS dated 3/5/2012 to customers. The letter identified the affected product and the reason for recall. BD has taken steps to modify the existing manufacturing and assembly processes to help reduce the potential for this condition. Questions regarding this issue should be directed to BD Global Technical Services at 1-800-631-0174 or email at www.bd.com/Vascutainer/contact.

Device

Device Recall BD Vacutainer Plastic Plasma Separator Tube (PST) Plus
  • Model / Serial
    Reference No.: 367960; Tube Size: 13 X 75. Reference Nos. 367961-367963, and 368035; Tube Size: 13 X 100; all lots
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    BD Vacutainer PST Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collection Tubes; Sterile; IVD; REF 367962; 4.5 mL, 13 X 100 mm; BD, Franklin Lakes, NJ USA; Made in USA. || Used in hospitals, outpatient clinics and physicians' offices to collect blood from patients for specialized chemistry testing.
  • 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