Z-1867-2013 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
865/25 ct boxes, 414/100 ct boxes, 307/500 ct boxes

Product Description

Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.

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.

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 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.