FDA-Device2013-08-07Class II
Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.
Mesa Laboratories, Inc., Bozeman Manufacturing Facility
Hazard
Mesa EZTest , Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims.
Sold states
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.
Affected count
865/25 ct boxes, 414/100 ct boxes, 307/500 ct boxes
Manufactured in
10 Evergreen Dr Ste E, N/A, Bozeman, MT, United States
Products
Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1867-2013Don't want to check this manually?
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