FDA-Device2024-03-27Class II
Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST"
Mckesson Medical-Surgical Inc. Corporate Office
Hazard
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.
Sold states
US Nationwide distribution in the states of AZ, PA and TX.
Affected count
25 units
Manufactured in
9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, VA, United States
Products
Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST"
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1313-2024Don't want to check this manually?
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