smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714
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-0205-2025
- 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 N/A, Lot Numbers: 6000465, 6000466
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.