Smiths Medical TranStar Pressure Transducers Recalled Due to Manufacturing Defect
Smiths Medical is recalling 1,000 units of medex TranStar DPT pressure transducers that may monitor inaccurately or interrupt monitoring due to a manufacturing defect. Users may be unable 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 an FDA Class II recall without reported hospitalizations, injuries, or deaths. However, the manufacturing defect creates a clear risk of harm to patients relying on accurate pressure monitoring, qualifying as a risk-of-harm product per the rubric criterion for Score 3.
Plain-English summary
Smiths Medical ASD, Inc. is recalling 1,000 units of the medex TranStar DPT (Disposable Pressure Transducer) with Stopcock & 30cc Flush, Product Code REF MX950SCNT, due to a manufacturing defect.
The defect may cause inaccurate pressure monitoring, interruption in pressure monitoring, or inability to zero the device. These issues can result from a leak within the transducer or a defect within the transducer chip.
The recalled product has been distributed worldwide. Affected lot numbers are 4293126, 4309186, 4316649, 4323123, 4328467, and 4346049.
The recalled product
- Product
- medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNT
- Manufacturer
- Smiths Medical ASD, Inc.
- Hazard
- pressure-monitoring-failure
- leak
- chip-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 (8)
- UDI/DI 50351688503938 (case)
- 10351688503930 (pouch)
- Lot Numbers: 4293126
- 4309186
- 4316649
- 4323123
- 4328467
- 4346049
Distribution
Distribution scope not specified by the agency.
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