Device product
medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1
Z-0203-2025
Product summary
- Event
- Event 95438
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3080 units
- Official record key
device-enforcement:Z-0203-2025
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 50351688518123 (case), 10351688518125 (pouch), Lot Numbers: 4282765, 4307302, 4309198, 4311461, 4316668, 4328487, 4350011, 4366881
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Manufacturing or process control
manufacturing defect