medical Class II Updated 2024-10-30

Smiths Medical ASD, Inc. recalls medex TranStar Single OR Set 1/EA, Product Code REF MX20846R

Recalled Product

medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2


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 50351688508780 (case), 10351688508782 (pouch) , Lot Numbers: 4282732, 4287721
View official government recall

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