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U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes. 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. Class II 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. 865/25 ct boxes, 414/100 ct boxes, 307/500 ct boxes Z-1867-2013
Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes. Lot No SR-444 Manufacture Date 2013 January 21 Expiration Date 2015 January 21; Lot No SR-445 Manufacture Date 2013 February 15 Expiration Date 2015 February 15. Lot No SR-447 Manufacture Date 2013 March 18 Expiration Date 2015 March 18. Class II Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims. 2447/100 count boxes Z-1868-2013
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