medex TranStar Pressure Monitoring Kit Recalled for Manufacturing Defect
Smiths Medical is recalling the medex TranStar 72-inch Double Monitoring Kit due to a manufacturing defect in the pressure transducer that may cause inaccurate pressure readings or monitoring interruptions. Approximately 6,590 units have been distributed worldwide.
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 recall receives a High (3) severity rating because the manufacturing defect presents a risk-of-harm in a medical device (FDA Class II) where malfunction could disrupt critical pressure monitoring. No illnesses, injuries, or deaths have been reported in the source material, and the hazard is theoretical rather than confirmed.
Plain-English summary
Smiths Medical ASD, Inc. is recalling the medex TranStar 72-inch (183 cm) Double Monitoring Kit (Product Code REF MX9502T) due to a manufacturing defect in the TranStar Disposable Pressure Transducer.
A leak within the transducer or a defect in the transducer chip can cause three types of failures: inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device. These failures could prevent accurate measurement during medical procedures.
The recall affects approximately 6,590 units distributed worldwide. The affected lot numbers are 4270150, 4277661, 4277716, and 4287633.
This is a Class II FDA medical device recall. The affected UDI codes are 50351688504041 (case) and 10351688504043 (pouch). Consult the official FDA recall notice for further instructions.
The recalled product
- Product
- medex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9502T
- Manufacturer
- Smiths Medical ASD, Inc.
- Hazard
- manufacturing-defect
- device-malfunction
- pressure-monitoring-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 (6)
- UDI/DI 50351688504041 (case)
- 10351688504043 (pouch)
- Lot Numbers: 4270150
- 4277661
- 4277716
- 4287633
Distribution
Distribution scope not specified by the agency.
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