Events

Recall of Device Recall Oxoid Antimicrobial Susceptibility Discs FOX30, Cefoxitin

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Remel Inc.

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
    63556
  • Event Risk Class
    Class 2
  • Event Number
    Z-0808-2013
  • Event Initiated Date
    2012-08-21
  • Event Date Posted
    2013-02-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114202
  • 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
    Susceptibility test discs, antimicrobial - Product Code JTN
  • Reason
    The firm is recalling the product because the cartridges may contain discs that have an insufficient dose of antibiotic.
  • Action
    The recalling firm sent a recall notification letter dated 8/17/ 2012 and 8/21/2012.

Device

Device Recall Oxoid Antimicrobial Susceptibility Discs FOX30, Cefoxitin
  • Model / Serial
    Lot 1186069
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution including the states of: CA, CT, GA, IA, KS, OK, RI, TX, WA, WI,
  • Product Description
    Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged with 50 discs per cartridge, 5 cartridges per box. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hants, UK.
  • Manufacturer
    Remel Inc

Manufacturer

Remel Inc
  • Manufacturer Address
    Remel Inc, 12076 Santa Fe Trail Dr, Lenexa KS 66215-3519
  • Manufacturer Parent Company (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA