Home / Recalls / Mesa Laboratories, Inc., Bozeman Manufacturing Facility / Z-1867-2013

Z-1867-2013 Class II Terminated

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

FDA device recall Z-1867-2013 was initiated by Mesa Laboratories, Inc., Bozeman Manufacturing Facility on June 4, 2013 and is designated Class II. 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. The recall status is terminated (terminated November 22, 2013). Affected quantity: 865/25 ct boxes, 414/100 ct boxes, 307/500 ct boxes.

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.