Events

Recall of Device Recall LICOX Complete Brain IMC Probe Kit, Model IM3.ST C

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

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
    31117
  • Event Risk Class
    Class 3
  • Event Number
    Z-0622-05
  • Event Initiated Date
    2005-01-21
  • Event Date Posted
    2005-03-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-07-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37179
  • 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
    Test, Sorbent, Fta-Abs - Product Code GMW
  • Reason
    Licox model c8.B temperature probes manufactured by gms mbh, an integra company, may exhibit progen (endotoxin) levels above the fda limit of 2.15 endotoxin units per device. elevated endotoxin levels may result in an increased patient risk of fever.
  • Action
    LICOX Model C8.B temperature probes and LICOX IM3.ST Complete Brain IMC Probe Kits manufactured by GMS mbH, an Integra company, may exhibit pyrogen (endotoxin) levels above the FDA limit of 2.15 endotoxin units per device. Elevated endotoxin levels may result in an increased patient risk of fever.

Device

Device Recall LICOX Complete Brain IMC Probe Kit, Model IM3.ST C
  • Model / Serial
    Lot numbers: 2506, 3904, 04779, 04795, 04835, 14716, 18141, 19059, 21044, 28800, 28806, 28806A, 47814, 050105, 619202, 619406, 619419, 619466, 619536, 619593, 619632, 619675, 619733, 619886, 619999, 620331/1
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    LA, CA, CO, DC, DE, FL, GA, IL, IN, LA, MA, MD, MI, MN, MT, NC, NE, NY, OH, OR, PA, SD, TN, TX, VA
  • Product Description
    LICOX Complete Brain IMC Probe Kit, Model IM3.ST C
  • Manufacturer
    Integra Neuro Sciences

Manufacturer

Integra Neuro Sciences
  • Manufacturer Address
    Integra Neuro Sciences, 5955 Pacific Center Blvd, San Diego CA 92121-4309
  • Source
    USFDA