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
  • 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
  • 1 Event

Manufacturer

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