Medex TranStar Pressure Transducer Recalled for Manufacturing Defect Affecting Monitoring
Smiths Medical is recalling 3080 medex TranStar pressure transducers with a manufacturing defect that may cause inaccurate, interrupted, or absent pressure monitoring. The defect stems from leaks or chip failures in the transducer.
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 involving a medical device with potential for patient harm if pressure monitoring fails. No illnesses or injuries have been reported. Per the severity rubric, a risk-of-harm product where injury has not yet been reported scores High (3).
Plain-English summary
Smiths Medical ASD, Inc. is recalling the medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK, Product Code REF MXG300243R1. This is a medical device used for pressure monitoring with a total of 3080 units identified in the recall.
The recall was initiated due to a manufacturing defect in the TranStar Disposable Pressure Transducer. The defect may originate from either a leak within the transducer or a defect within the transducer chip. These defects may cause users to experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device.
The product has been distributed worldwide. Affected units are identified by lot numbers: 4282765, 4307302, 4309198, 4311461, 4316668, 4328487, 4350011, and 4366881.
The recalled product
- Product
- medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1
- Manufacturer
- Smiths Medical ASD, Inc.
- Hazard
- monitoring-failure
- manufacturing-defect
- transducer-failure
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 50351688518123 (case)
- 10351688518125 (pouch)
- Lot Numbers: 4282765
- 4307302
- 4309198
- 4311461
- 4316668
- 4328487
- 4350011
- 4366881
Distribution
Distribution scope not specified by the agency.
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