Smiths Medical ASD, Inc.: medex TranStar Disposable Transducer 1/EA, Product Code REF MX950

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: 1100 units Lot/code info: UDI/DI 50351688504126 (case), 10351688504128 (pouch), Lot Numbers: 4293125, 4328466, 4277644, 4349995, 4363255

UPC codes

50351688504126, 10351688504128

Source

Official record: FDA (Device enforcement) ↗

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