medical Class II Updated 2024-10-30

Smiths Medical ASD, Inc. recalls medex Arterial Kit 1/EA, Product Code REF MX7827

Recalled Product

medex Arterial Kit 1/EA, Product Code REF MX7827

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 50351688505185 (case), 10351688505187 (pouch), Lot Numbers: 4282733, 4319605, 4340472, 4355338, 4390060, 4411161
View official government recall

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