Pressure Monitoring Kit Recalled for Manufacturing Defect and Malfunction
The medex TranStar 84in Single Monitoring Kit is being recalled due to manufacturing defects in its disposable pressure transducer. The defect may cause inaccurate pressure readings, interruption of 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 recall for a pressure monitoring device with manufacturing defects that could impair critical hemodynamic monitoring function. No illnesses or injuries have been reported, making this a risk-of-harm situation without confirmed patient harm.
Plain-English summary
The medex TranStar 84in (213cm) Single Monitoring Kit (Product Code REF MX9505T), manufactured by Smiths Medical ASD, Inc., is being recalled due to a manufacturing defect. Approximately 1.16 million units have been distributed worldwide.
The defect affects the disposable pressure transducer component and may result in a leak within the transducer or a defect within the transducer chip. This can cause inaccurate pressure monitoring, interruption of monitoring, or inability to zero the device.
Healthcare providers and users in possession of affected units (identified by specific lot numbers provided by the FDA) should contact Smiths Medical ASD, Inc. for guidance on device replacement or return. Affected units should not be used until replacement guidance is provided.
The recalled product
- Product
- medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T
- Manufacturer
- Smiths Medical ASD, Inc.
- Hazard
- pressure-transducer-defect
- device-malfunction
- monitoring-interruption
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 (20)
- UDI/DI 50351688503990 (case)
- 10351688503992 (pouch)
- Lot Numbers: 4277670
- 4287645
- 4287649
- 4299776
- 4277696
- 4308930
- 4299811
- 4308934
- 4299812
- 4323148
- 4264943
- 4264939
- 4277694
- 4264950
- 4299779
- 4308962
- 4323175
- 4328515
Distribution
Distribution scope not specified by the agency.
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