Smiths Medical TranStar Patient Mount Monitoring Kit recalled for pressure measurement defects
Smiths Medical recalls the medex TranStar Patient Mount Monitoring Kit (1,740 units) due to manufacturing defects that may cause inaccurate or interrupted pressure monitoring.
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 FDA Class II recall involves a manufacturing defect in a medical monitoring device that could cause loss of critical patient monitoring function. No illnesses or injuries have been reported, but the device's inability to accurately monitor or function represents a risk of harm in clinical settings.
Plain-English summary
Smiths Medical ASD, Inc. is recalling the medex TranStar Patient Mount Monitoring Kit, Product Code REF MX9501T, due to a manufacturing defect in the TranStar Disposable Pressure Transducer. The defect may result in inaccurate pressure monitoring, interruption of pressure monitoring, or inability to zero the device.
The defect stems from either a leak within the pressure transducer itself or a defect in the transducer chip. These functional failures could prevent healthcare providers from obtaining accurate or continuous pressure readings during patient monitoring.
A total of 1,740 units have been distributed worldwide. Affected lot numbers are 4304896, 4346065, 4355385, and 4376424. Healthcare facilities that received this monitoring kit should cease use of affected units and contact Smiths Medical ASD, Inc. for replacement or return instructions.
The recalled product
- Product
- medex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501T
- Manufacturer
- Smiths Medical ASD, Inc.
- Hazard
- inaccurate-pressure-monitoring
- device-malfunction
- 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 (6)
- UDI/DI 50351688504072 (case)
- 10351688504074 (pouch)
- Lot Numbers: 4304896
- 4346065
- 4355385
- 4376424
Distribution
Distribution scope not specified by the agency.
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