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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 Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code PL 200, Distributor Product Code MDS200500IR 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
Recall Number Z-1828-2013
Classification Class II
Code Info Affected Biological Indicator Lot No.:130401
Product Distributed Qty 3535 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.
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