Device Recall Medline Steam Biological Indicators

  • Model / Serial
    Affected Biological Indicator Lot No.: S-444
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.
  • Product Description
    Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributor Product Code MDS200525 || EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121¿C, 132¿C, 134¿C and 135¿C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Steritec Products Mfc. Co., Inc., 74 Inverness Drive East, Englewood CO 80112-5114
  • Manufacturer Parent Company (2017)
  • Source
    USFDA