Events

Recall of Oxacillin Screen Agar, Catalog 221952, in disposable plastic media plates, packaged in boxes of 10 plates/box.

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
    32943
  • Event Risk Class
    Class 2
  • Event Number
    Z-1458-05
  • Event Initiated Date
    2005-07-28
  • Event Date Posted
    2005-08-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-10-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41123
  • 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, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth - Product Code JTZ
  • Reason
    Microbiological media for antibiotic susceptibility testing gives false test results.
  • Action
    The recalling firm notified distributors and direct accounts by fax, e-mail, and letters on 07/28/2005. The notifications advised of false resistant results with control organisms known to be oxcacillin susceptible. Customers were instructed to discontinue use of the lot and discard for replacement. Distributors were requested to discontinue distribution and provide consignee list for subsequent notification. Response forms are included with the recall letters.

Device

Oxacillin Screen Agar, Catalog 221952, in disposable plastic media plates, packaged in boxes of 1...
  • Model / Serial
    Lot #5140549, EXP 8/17/05
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was sold to distributors and direct account end-users worldwide including government facilities.
  • Product Description
    Oxacillin Screen Agar, Catalog 221952, in disposable plastic media plates, packaged in boxes of 10 plates/box.
  • 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