Events

Recall of BD Vacutainer Urine Complete Kit

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
    53650
  • Event Risk Class
    Class 3
  • Event Number
    Z-1026-2010
  • Event Initiated Date
    2009-10-12
  • Event Date Posted
    2010-03-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-03-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86268
  • 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
    Culture media, non-propagating transport - Product Code JTW
  • Reason
    A small amount of discoloration was noted on towelettes included in bd vacutainer urine collection kits. the entire kit components retain sterile interiors and no viable growth was detected on the towelettes.
  • Action
    Recall notification letters were sent on 10/12/09 with return receipt requested. Customers were advised to contact your SO Sales Consultant for additional information, via e-mail at Vacutainer_TechServices@SD.com or via telephone at 1-800-6310174.

Device

BD Vacutainer Urine Complete Kit
  • Model / Serial
    Catalog number 364988, lot number 9125270, Exp. 5/2011; lot number 9148024, Exp. 6/2011
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution to hospitals and medical device distributors.
  • Product Description
    BD Vacutainer Urine Complete Kit with UA tube and C&C; Preservative Tube for Midstream Specimens. C&S; Preservative Boric Acid 6.70mg/ml, Sodium Formate 3.35 mg/ml || PLUS Plastic, Sterile Cup and Tube Interiors. Store at 4-25 degrees C., for In Vitro Diagnostic Use. || Becton Dickinson and Company, Franklin Lakes, NJ; || Kit contains Sterile Screw-Cap Collection Cup and integrated Transfer Device and 10 mL, 16x100 mm Plus Plastic Round Bottom Tube with Preservative for urinalysis and 5.0 mL 16x75mm Glass C&S; Preservative Tube and Castile Soap Towelettes.
  • 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