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Steritec Products Mfc. Co., Inc. recalls Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriTec Product Code PL 160/A, Distributor Produ
Recalled August 7, 2013 · FDA recall Z-1829-2013 · Steritec Products Mfc
Hazard
Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims. · FDA Class II
Units
360 units
Sold at
Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.
Description
Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.
Product
Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriTec Product Code PL 160/A, Distributor Product Code T40311PE SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132¿C (270¿F) for 3 minutes or longer. The Instant Readout Integrator Card gives the operator a prediction of the biological test outcome.
Manufacturer(s)
Steritec Products Mfc. Co., Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →