medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1
This recall is currently active, issued October 23, 2024. It was issued by Smiths Medical Asd Inc..
- Company
- Smiths Medical Asd Inc.
- Recall Initiated
- September 24, 2024
- Posted
- October 23, 2024
- Recall Number
- Z-0203-2025
- Quantity
- 3080 units
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
UDI/DI 50351688518123 (case), 10351688518125 (pouch), Lot Numbers: 4282765, 4307302, 4309198, 4311461, 4316668, 4328487, 4350011, 4366881
Root Cause
Process control
Action Taken
Smiths medical issued an URGENT MEDICAL DEVICE REMOVAL notice to its consignees on 09/24/2024 via traceable mailing. The notice explained the issue, potential risk, and requested the destruction of all affected product. Distributors were directed to forward the notice to their customers.