Smiths Medical ASD, Inc.: medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548

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: 3490 units Lot/code info: UDI/DI 50351688503006 (case), 10351688503008 (pouch), Lot Numbers: 4221225, 4250996, 4297929, 4304897,4316671, 4323138, 4328494, 4387189, 4404713

UPC codes

50351688503006, 10351688503008

Source

Official record: FDA (Device enforcement) ↗

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