FDA-Device2024-10-30Class II
medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9543
Smiths Medical ASD, Inc.
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.
Sold states
Worldwide distribution.
Affected count
800 units
Manufactured in
6000 Nathan Ln N, N/A, Minneapolis, MN, United States
Products
medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9543
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0197-2025Don't want to check this manually?
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