Smiths Medical ASD, Inc.: medex TranStar Single ICP Set 1/EA, Product Code REF MX20897

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: 100 units Lot/code info: UDI/DI 50351688508551 (case), 10351688508553 (pouch), Lot Numbers: 4323116

UPC codes

50351688508551, 10351688508553

Source

Official record: FDA (Device enforcement) ↗

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