Smiths Medical SurgiVet pressure transducer recalled for monitoring failures
Smiths Medical is recalling SurgiVet Advisor Tech Accessories due to manufacturing defects in the pressure transducer that may cause inaccurate, interrupted, or failed pressure monitoring.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries attributed to the defect. The potential for inaccurate or interrupted pressure monitoring in a medical device represents a risk-of-harm scenario, but without reported actual harm, this meets the High severity criteria per the rubric.
Plain-English summary
Smiths Medical ASD, Inc. is recalling the SurgiVet Advisor Tech Accessories (Product Code REF V2714) with affected lot numbers 6000465 and 6000466. The product is distributed worldwide due to a manufacturing defect in the TranStar Disposable Pressure Transducer component.
The defect can manifest as either a leak within the pressure transducer or a defect in the transducer chip. Users may experience inaccurate pressure monitoring, interruption in pressure monitoring, or inability to zero the device as a result of this manufacturing defect.
The recalled product
- Product
- smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714
- Manufacturer
- Smiths Medical ASD, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI/DI N/A
- Lot Numbers: 6000465
- 6000466
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 24 recalled by Smiths Medical ASD, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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