Z-1867-2013 Class II Terminated
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.