Recall Z-1313-2024— Mckesson Medical-Surgical Inc. Corporate Office
Class II · Ongoing
Class II FDA medical device recall by Mckesson Medical-Surgical Inc. Corporate Office, initiated 2024-01-09. FDA's recall record names no specific 510(k) clearance for this event. Product: Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST". 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..
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-01-09
- Firm location
- Richmond, VA, United States
Product description
Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST"
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.