Device product
medex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9504T
Z-0191-2025
Product summary
- Event
- Event 95438
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5880 units
- Official record key
device-enforcement:Z-0191-2025
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 50351688504034 (case), 10351688504036 (pouch), Lot Numbers: 4277662, 4287634, 4289405
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Manufacturing or process control
manufacturing defect