medex TranStar Neonatal Monitoring Kit Recalled Due to Pressure Transducer Defect
Smiths Medical is recalling the medex TranStar Neonatal Monitoring Kit due to manufacturing defects in the pressure transducer that may cause inaccurate readings or monitoring failures.
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 an FDA Class II recall of neonatal pressure-monitoring equipment with manufacturing defects that can cause inaccurate readings or monitoring failure. No illnesses or injuries have been reported, but the device is critical for patient monitoring in vulnerable neonatal patients, meeting the rubric criterion for High severity: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
The medex TranStar Neonatal Monitoring Kit (Product Code REF MX9530T) manufactured by Smiths Medical ASD, Inc. is being recalled due to a manufacturing defect. The kit is used for pressure monitoring in neonatal patients.
A defect in the TranStar Disposable Pressure Transducer or its chip can cause inaccurate pressure readings, interruptions in monitoring, or the inability to zero the device. These defects may result in unreliable pressure measurements during critical patient care.
Approximately 2,580 units were distributed worldwide. The recall affects specific lot numbers: 4282765, 4307302, 4309198, 4311461, 4316668, 4328487, 4350011, 4366881.
No illnesses or injuries have been reported in connection with this defect.
The recalled product
- Product
- medex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530T
- Manufacturer
- Smiths Medical ASD, Inc.
- Hazard
- inaccurate-pressure-readings
- monitoring-failure
- manufacturing-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 (10)
- UDI/DI 50351688503280 (case)
- 10351688503282 (pouch)
- Lot Numbers: 4282765
- 4307302
- 4309198
- 4311461
- 4316668
- 4328487
- 4350011
- 4366881
Distribution
Distribution scope not specified by the agency.
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