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Recall Observatory FDA recall evidence

Device product

smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714

Z-0205-2025

September 24, 2024

Class II

Product summary

Firm
Smiths Medical ASD, Inc.
Event
Event 95438
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-0205-2025

Official wording

Reason: 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.

Code information: UDI/DI N/A, Lot Numbers: 6000465, 6000466

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    manufacturing defect