Events

Recall of Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitalex), microbiological media plates. || Catalog # 221267

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
    25158
  • Event Risk Class
    Class 2
  • Event Number
    Z-0345-03
  • Event Initiated Date
    2002-11-18
  • Event Date Posted
    2002-12-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-05-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25313
  • 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, For Isolation Of Pathogenic Neisseria - Product Code JTY
  • Reason
    Microbiological media may exhibit no growth or reduced colony size of haemophilus species.
  • Action
    Becton Dickinson notified distributors by fax on 11/18/02 to discard inventory. Firm additionally notified distributors on 11/21/02 to include three additional lots of agar for recall. End users were notified by letter 11/21/02 to discard inventory for replacement, and return reply form.

Device

Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitalex), microbiological media plates. || C...
  • Model / Serial
    Lots: 2213201 EXP 11/25/02 2213211 EXP 11/26/02 2261524 EXP 1/14/02 2246310 EXP 1/1/03 2261552 EXP 1/15/03 2276445 EXP 1/29/03
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was sold to distributors and subsequently distributed to medical facility end users nationwide and internationally.
  • Product Description
    Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitalex), microbiological media plates. || Catalog # 221267
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Manufacturer Address
    Becton Dickinson & Co., 7 Loveton Circle, Sparks MD 21152
  • Source
    USFDA