Device product
medex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9502T
Z-0190-2025
Product summary
- Event
- Event 95438
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6590 units
- Official record key
device-enforcement:Z-0190-2025
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 50351688504041 (case), 10351688504043 (pouch), Lot Numbers: 4270150, 4277661, 4277716, 4287633
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Manufacturing or process control
manufacturing defect