Vascular Technology Recalls Sterile Doppler Probes Due to Barrier Penetration
Vascular Technology, Inc. is recalling 34 sterile Doppler probes because the sterile barrier may have been penetrated, potentially rendering the devices unsterile.
What this means for you
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: The recall involves a sterile medical device where the barrier integrity is compromised, creating a risk of infection (risk-of-harm product). No specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Vascular Technology, Inc. is recalling 34 units of the 07-150-12 MIZUHO, MINI, SLIM, STERILE Doppler probe (Reference 138665, Lot Number 1516-37698). The recall was initiated after a report that the product's sterile barrier had been penetrated. This defect could render the product unsterile, posing a risk of infection if used as intended for intraoperative and transcutaneous evaluation of blood flow.
The affected units were distributed worldwide, including in the United States (specifically California), Australia, the United Kingdom, and Taiwan. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare providers and facilities that have received these specific units should stop using them immediately. Users should contact Vascular Technology, Inc. for instructions on how to return or dispose of the affected probes. Consumers are not expected to have these medical devices in their homes, but any individual who has used a probe from this lot should consult their healthcare provider if they have concerns about potential infection.
The recalled product
- Product
- 07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
- Manufacturer
- Vascular Technology, Inc.
- Affected units
- 34
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 (1)
- LOT NUMBER 1516-37698
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 4 recalled by Vascular Technology, 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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