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

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: 2232 units Lot/code info: UDI/DI 50351688505185 (case), 10351688505187 (pouch), Lot Numbers: 4282733, 4319605, 4340472, 4355338, 4390060, 4411161

UPC codes

50351688505185, 10351688505187

Source

Official record: FDA (Device enforcement) ↗

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