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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 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
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
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