Smiths Medical medex TranStar Pressure Monitoring Kits Recalled for Manufacturing Defect
Smiths Medical is recalling 5,880 medex TranStar pressure monitoring kits worldwide due to a manufacturing defect that may cause inaccurate readings, monitoring interruption, or inability to zero the device.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall with a manufacturing defect affecting measurement accuracy in a critical monitoring application. No illnesses, injuries, or hospitalizations have been reported. The defect poses a risk of harm as a "risk-of-harm product where injury has not yet been reported," meeting the High (3) severity criterion.
Plain-English summary
Smiths Medical ASD, Inc. is recalling the medex TranStar 60in (152cm) Single Monitoring Kit (Product Code REF MX9504T), a disposable pressure monitoring device used in clinical settings. The recall affects approximately 5,880 units distributed worldwide.
The recalled kits contain a manufacturing defect in the TranStar Disposable Pressure Transducer that may cause inaccurate pressure readings, interruption of pressure monitoring, or inability to zero the device. The defect results from either a leak within the transducer or a defect within the transducer chip.
Affected lot numbers are 4277662, 4287634, and 4289405. Device UDI identifiers are 50351688504034 (case) and 10351688504036 (pouch). The FDA recall number is Z-0191-2025.
The recalled product
- Product
- medex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9504T
- Manufacturer
- Smiths Medical ASD, Inc.
- Hazard
- inaccurate-pressure-reading
- monitoring-interruption
- transducer-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI/DI 50351688504034 (case)
- 10351688504036 (pouch)
- Lot Numbers: 4277662
- 4287634
- 4289405
Distribution
Distribution scope not specified by the agency.
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