Device product
Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST"
Z-1313-2024
Product summary
- Event
- Event 94024
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 25 units
- Official record key
device-enforcement:Z-1313-2024
Official wording
Reason: Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.
Code information: Catalogue Number: LCC101; UDI/DI: 10724995220072
Distribution pattern: US Nationwide distribution in the states of AZ, PA and TX.
Derived failure modes
-
Unknown
Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.