medical Class II Updated 2024-10-30

Smiths Medical ASD, Inc. recalls medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 3

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Worldwide distribution.
Lot/Code Info: UDI/DI 50351688503006 (case), 10351688503008 (pouch), Lot Numbers: 4221225, 4250996, 4297929, 4304897,4316671, 4323138, 4328494, 4387189, 4404713
View official government recall

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