Mckesson Medical-Surgical Inc. Corporate Office Recall 94024
Description: Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST"
Mckesson Medical-Surgical Inc. Corporate Office Recall 94024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1313-2024 |
| Event ID | 94024 |
| Event Description | Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST" |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of AZ, PA and TX. |
| Quantity | 25 units |
| Recall 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. |
| Device Classification | 20240327 |
| Device Code Info | Catalogue Number: LCC101; UDI/DI: 10724995220072 |
| Center Classification Date | 20240319 |
| Recall Initiation Date | 20240109 |
| Recalling Firm | Mckesson Medical-Surgical Inc. Corporate Office |
| Initial Notification | Telephone |
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