Device product
medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260
Z-0204-2025
Product summary
- Event
- Event 95438
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1640 units
- Official record key
device-enforcement:Z-0204-2025
Official wording
Reason: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
Code information: UDI/DI 50351688518833 (case), 10351688518835 (pouch), Lot Numbers: 4270120, 4297963, 4316640, 4319604, 4323118, 4287727, 4359814, 4387976, 4340473
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Manufacturing or process control
manufacturing defect