Home / Recalls / Mesa Laboratories, Inc., Bozeman Manufacturing Facility / Z-1868-2013

Z-1868-2013 Class II Terminated

Recalled by Mesa Laboratories, Inc., Bozeman Manufacturing Facility — Bozeman, MT

Recall Details

Product Type: Devices
Report Date: August 7, 2013
Initiation Date: June 4, 2013
Termination Date: November 22, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2447/100 count boxes

Product Description

Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.

Reason for Recall

Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims.

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.

Code Information

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.