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U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

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Product Detail

Product Description EZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400 EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121°C, 132°C, 134°C and 135°C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours.
Recall Number Z-1824-2013
Classification Class II
Code Info Affected Biological Indicator Lot No.: S-444
Product Distributed Qty 14,900 units
Reason For Recall 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.

Event Detail

Event Id 65473
Product Type Devices
Status Ongoing
Recalling Firm Steritec Products Mfc. Co., Inc.
City Englewood
State CO
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-10
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.