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Smiths Medical ASD, Inc. recalls medex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9504T
Recalled October 30, 2024 · FDA recall Z-0191-2025 · Smiths Medical ASD
Hazard
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip. · FDA Class II
Units
5880 units
Sold at
Worldwide distribution.
Description
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
Product
medex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9504T
Manufacturer(s)
Smiths Medical ASD, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →