TranStar Disposable Pressure Transducer Kit recalled for manufacturing defect
Smiths Medical is recalling the medex TranStar Pressure Transducer Kit due to manufacturing defects that may cause inaccurate pressure monitoring or inability 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 device recall for a risk-of-harm product where pressure monitoring failure could affect patient safety, but no injuries or illnesses have been reported. The hazard is based on the manufacturing defect, meeting the criteria for a High severity rating.
Plain-English summary
The medex TranStar Kit with Stopcock (Product Code REF MX20740), manufactured by Smiths Medical ASD, Inc., is being recalled worldwide due to manufacturing defects. The defects may result in a leak within the Disposable Pressure Transducer or a defect within the Disposable Pressure Transducer chip.
Users of the affected kit may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device. These failures could prevent accurate monitoring of patient pressure levels during medical procedures.
If you have the medex TranStar Kit with Stopcock (Product Code REF MX20740) with Lot Number 4273609, discontinue use immediately and contact Smiths Medical ASD, Inc. for guidance on replacement or return instructions. Healthcare facilities should verify their inventory against the affected lot number.
The recalled product
- Product
- medex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740
- Manufacturer
- Smiths Medical ASD, Inc.
- Hazard
- pressure-transducer-defect
- 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 (3)
- UDI/DI 50351688508957 (case)
- 10351688508959 (pouch)
- Lot Numbers: 4273609
Distribution
Distribution scope not specified by the agency.
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