Smiths Medical ASD, Inc.: medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547

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: 3280 units Lot/code info: UDI/DI 50351688503013 (case), 10351688503015 (pouch), Lot Numbers: 4223699, 4248326, 4297927, 4323137, 4340498, 4346068, 4350022

UPC codes

50351688503013, 10351688503015

Source

Official record: FDA (Device enforcement) ↗

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