medical Class II Updated 2024-10-30

Smiths Medical ASD, Inc. recalls medex TranStar Neonatal Monitoring Kit 10/EA, Product Code R

Recalled Product

medex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530T

Hazard / Issue

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.

Issued by

FDA

Distribution: Worldwide distribution.
Lot/Code Info: UDI/DI 50351688503280 (case), 10351688503282 (pouch), Lot Numbers: 4282765, 4307302, 4309198, 4311461, 4316668, 4328487, 4350011, 4366881
View official government recall

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