Device product
Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.
Z-1868-2013
Product summary
- Event
- Event 65544
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2447/100 count boxes
- Official record key
device-enforcement:Z-1868-2013
Official wording
Reason: Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims.
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.
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.
Derived failure modes
-
Unknown
Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims.