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Mesa Laboratories Inc recalls ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Num
Recalled February 1, 2017 · FDA recall Z-1104-2017 · Mesa Laboratories
Hazard
Product resistance has fallen outside of label claim within expiry. · FDA Class II
Units
328/ 50-count/ boxes; 16,400 individual units
Sold at
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.
Description
Product resistance has fallen outside of label claim within expiry.
Product
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.
Manufacturer(s)
Mesa Laboratories Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →