Events

Recall of Device Recall CM0405 MuellerHinton Broth IVD

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
    78470
  • Event Risk Class
    Class 2
  • Event Number
    Z-0209-2018
  • Event Initiated Date
    2017-11-02
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159632
  • 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
    Product may have incorrect cation information detailed on the product label.
  • Action
    The recalling firm issued letters dated 11/2/2017 via regular mail on 11/2/2017 notifying the customer of the incorrect labeling information and providing them the correct labeling information.

Device

Device Recall CM0405 MuellerHinton Broth IVD
  • Model / Serial
    Lot 1865331, Exp. 06/2021
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution was made to AL, MD, ME, NC, and TN. There was no foreign/military/government distribution.
  • Product Description
    CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres.
  • 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