Device product
Cardinal Steam Biological Indicator, SteriTec Product Code PL 218, Distributor Product Code T40360EZ EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121¿C, 132¿C, 134¿C and 135¿C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours.
Z-1823-2013
Product summary
- Event
- Event 65473
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200
- Official record key
device-enforcement:Z-1823-2013
Official wording
Reason: Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.
Code information: Affected Biological Indicator Lot No.: S-444
Distribution pattern: Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.
Derived failure modes
-
Unknown
Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.