Smiths Medical ASD, Inc.: medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution. Quantity: 3080 units Lot/code info: UDI/DI 50351688518123 (case), 10351688518125 (pouch), Lot Numbers: 4282765, 4307302, 4309198, 4311461, 4316668, 4328487, 4350011, 4366881

UPC codes

50351688518123, 10351688518125

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.