Smiths Medical ASD, Inc. recalls medex TranStar Disposable Transducer 1/EA, Product Code REF MX950
- Recall date
- September 24, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0188-2025
- FDA classification
- Class II
- Brand / firm
- Smiths Medical ASD, Inc.
- Sold / distributed
- Worldwide distribution.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
medex TranStar Disposable Transducer 1/EA, Product Code REF MX950
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