Device product
smiths medical medex HemoDraw Plus Closed Blood Sampling Set with LogiCal Pressure Monitoring System, Model Numbers: a) MX961H182P1 b) MX961H212P1 c) MX962H182P1 d) MX962H212P1
Z-0093-2022
Product summary
- Event
- Event 88667
- Status
- Terminated
- Classification
- Class II
- Quantity
- 140 units
- Official record key
device-enforcement:Z-0093-2022
Official wording
Reason: Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Code information: All codes
Distribution pattern: Austria, France, Germany, Great Britain, and Saudi Arabia
Derived failure modes
-
Unknown
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.