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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 Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.
Recall Number Z-1867-2013
Classification Class II
Code Info Lot No S-444 Manufacture Date 2013 January 21 Expiration Date 2015 January 21; Lot No S-445 Manufacture Date 2013 February 15 Expiration Date 2015 February 15 ; Lot No S-447 Manufacture Date 2013 March 18 Expiration Date 2015 March 18.
Product Distributed Qty 865/25 ct boxes, 414/100 ct boxes, 307/500 ct boxes
Reason For Recall Mesa EZTest , Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims.

Event Detail

Event Id 65544
Product Type Devices
Status Ongoing
Recalling Firm Mesa Laboratories, Inc., Bozeman Manufacturing Facility
City Bozeman
State MT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-04
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Worldwide Distribution: US (nationwide) and countries of: Australia, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Egypt, Greece, India,Israel, Japan, Jordan, Malaysia, Mexico, Milanese, Netherlands, Peru, Portugal, Pozan, Romania, Spain, Sweden, Taiwan, Thailand, United Kingdom, and Uruguay.