FDA-Device2017-02-01Class II
ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contains 50 Ampoules/Box. Product Usage: Biological indicator for steam sterilization at 121 deg C intended for use by a health care provider to accompany products being sterilized through steam sterilization procedure and to monitor adequacy of sterilization.
Mesa Laboratories Inc
Hazard
Product resistance has fallen outside of label claim within expiry.
Sold states
Product was distributed to: AL, AR, CA, FL, IA, MO, NE, NC, NY, OH, and WA. The product was also distributed internationally, including Mexico and Canada. There was no goverment or military distribution.
Affected count
328/ 50-count/ boxes; 16,400 individual units
Manufactured in
PO Box 27261, 8607 Park Dr, Omaha, NE, United States
Products
ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contains 50 Ampoules/Box. Product Usage: Biological indicator for steam sterilization at 121 deg C intended for use by a health care provider to accompany products being sterilized through steam sterilization procedure and to monitor adequacy of sterilization.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1104-2017Don't want to check this manually?
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