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FDAApril 4, 2016device

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...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Product resistance has fallen outside of label claim within expiry.

What to do

FDA enforcement status: Terminated

Brands named

mesa laboratoriesmesa

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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... — Recall Details · AllClear