Events

Recall of BD Probetec" ET CT/GC Endocervical Specimen Collection and Dry Transport SystemPink Cap

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Becton Dickinson & Co..

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
    54152
  • Event Risk Class
    Class 2
  • Event Number
    Z-0969-2010
  • Event Initiated Date
    2009-09-18
  • Event Date Posted
    2010-03-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-03-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87682
  • 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
    DNA-reagents, neisseria - Product Code MKZ
  • Reason
    Product was shipped beyond its expiration date.
  • Action
    The recalling firm notified end users by letter flagged as "Urgent Product Recall" on 09/18/09. The notification advised that the referenced lot number had been correctly labeled with expiration date but had been shipped after the labeled date. End users were instructed to discontinue use discard product for replacement and return enclosed response form. If further assistance is needed regarding replacements, please contact SD Customer Service Department at 1-800-675-0908. For all other inquiries, please contact SD Technical Services Department at 1-800-638-8663.

Device

BD Probetec" ET CT/GC Endocervical Specimen Collection and Dry Transport SystemPink Cap
  • Model / Serial
    Lot 7016132, Exp date 01/17/09.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The product was sold for distribution to clinical laboratories nationwide and to the firm's international affiliate in Australia.
  • Product Description
    BD Probetec" ET CT/GC Endocervical Specimen Collection and Dry Transport System-Pink Cap, Catalog number 440476, packed in shelfpack unit of 100 swabs.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Manufacturer Address
    Becton Dickinson & Co., 7 Loveton Cir, Sparks MD 21152-9212
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA