Events

Recall of Device Recall Mesa Labs, ETIGAM BrightCheq, and Getinge Assure Accufast

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mesa Laboratories, Inc., Bozeman Manufacturing Facility.

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
    65544
  • Event Risk Class
    Class 2
  • Event Number
    Z-1868-2013
  • Event Initiated Date
    2013-06-04
  • Event Date Posted
    2013-08-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-11-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120281
  • 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
    Indicator, biological sterilization process - Product Code FRC
  • Reason
    Self-contained steam biological indicator, are recalled because mesa recently determined that the read out time is not in specification with the label claims.
  • Action
    Mesa Labs sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 7, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. For questions contact Mesa Labs at BI-Support@mesalabs.com.

Device

Device Recall Mesa Labs, ETIGAM BrightCheq, and Getinge Assure Accufast
  • Model / Serial
    Lot No SR-444 Manufacture Date 2013 January 21 Expiration Date 2015 January 21;  Lot No SR-445 Manufacture Date 2013 February 15 Expiration Date 2015 February 15.  Lot No SR-447 Manufacture Date 2013 March 18 Expiration Date 2015 March 18.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: Australia, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Egypt, Greece, India,Israel, Japan, Jordan, Malaysia, Mexico, Milanese, Netherlands, Peru, Portugal, Pozan, Romania, Spain, Sweden, Taiwan, Thailand, United Kingdom, and Uruguay.
  • Product Description
    Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. || Intended for use in determining the efficacy of steam sterilization processes.
  • Manufacturer
    Mesa Laboratories, Inc., Bozeman Manufacturing Facility

Manufacturer

Mesa Laboratories, Inc., Bozeman Manufacturing Facility
  • Manufacturer Address
    Mesa Laboratories, Inc., Bozeman Manufacturing Facility, 10 Evergreen Dr Ste E, Bozeman MT 59715-2457
  • Manufacturer Parent Company (2017)
    Mesa Laboratories Inc
  • Source
    USFDA