Events

Recall of Device Recall BD Vacutainer C&S; Transfer Straw Kit C&S; Preservative Plus Urine Tube

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
    64494
  • Event Risk Class
    Class 3
  • Event Number
    Z-1056-2013
  • Event Initiated Date
    2013-02-14
  • Event Date Posted
    2013-04-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116319
  • 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, specimen, sterile - Product Code FMH
  • Reason
    The bd vacutainer urinalysis transfer straw kit #364991, lot 1335484 has preprinted polybags which are incorrectly labeled as catalog #364953. bd advises any customer who purchased this kit that the tube in this kit is not a c&s; tube. if a customer relies solely on the polybag labeling and uses the tube inside the kit for the purpose of collecting urine for culture and sensitivity, it is possible.
  • Action
    BD Diagnostics sent a "Product Advisory Notice" dated February 14, 2013 via UPS Second Day Air to all end user customers. The notice advises customers of the product issue, identifies affected product and provides instructions on how to handle affected product. For questions regarding this recall call 201-847-5033.

Device

Device Recall BD Vacutainer C&S; Transfer Straw Kit C&S; Preservative Plus Urine Tube
  • Model / Serial
    Catalog #3694991 appears as Catalog #364953 (Lot #1335484)
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including Arizona, California, Colorado, Georgia, Florida, Illinois, Iowa, Kentucky, Louisiana, Maryland, Massachussets, Michigan, Minnesota, Missouri, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington DC, Washington, West Virginia, and Wisconsin.
  • Product Description
    BD Vacutainer C&S; Transfer Straw Kit C&S; Preservative Plus Urine Tube. 4.0 ml, 13 X 75 mm STERILE REF 364953. Becton Dickinson & Company, Franklin Lakes, NJ USA, || The kit consists of a transfer straw and urinalysis tube intended for UA chemistry urine 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