medical Class II Updated 2024-10-30

Smiths Medical ASD, Inc. recalls medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product

Recalled Product

medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260

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 50351688518833 (case), 10351688518835 (pouch), Lot Numbers: 4270120, 4297963, 4316640, 4319604, 4323118, 4287727, 4359814, 4387976, 4340473
View official government recall

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