Events

Recall of Device Recall CXM 30

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
    25250
  • Event Risk Class
    Class 3
  • Event Number
    Z-0613-03
  • Event Initiated Date
    2002-12-05
  • Event Date Posted
    2003-03-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-03-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25822
  • 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
    Packages of cefuroxime susceptibility disks erroneously contained cefaclor susceptibility disks.
  • Action
    Recall letters dated 12/5/02 were issued requesting destruction of the product by the customer.

Device

Device Recall CXM 30
  • Model / Serial
    Lot Number: 254243 - Exp. 09/04
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed nationwide to 62 medical facilities including 3 military and 4 government accounts. No foreign accounts were reported.
  • Product Description
    REMEL CXM 30 Cefuroxime 30 mcg, Antimicrobial Susceptibility Test Disk, 50 disks to a cartridge, 5 cartridges to a kit, catalog Number 33999. The label shows the product is ''Mfg for'' REMEL, Lenexa,KS.
  • Manufacturer
    Remel, Inc.

Manufacturer

Remel, Inc.
  • Manufacturer Address
    Remel, Inc., 12076 Santa Fe Dr, Lenexa KS 66215
  • Source
    USFDA