Vascular Technology Recalls VTI Bayonet Doppler Probes Due to Sterility Concerns
Vascular Technology, Inc. is recalling 25 VTI Bayonet 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 risk-of-harm product (unsterile medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Vascular Technology, Inc. is recalling 25 units of the VTI Bayonet Doppler, 20MHz Doppler Probe, Slim, BX 4, REF 108660. The recall was initiated because the product's sterile barrier may have been penetrated, which could render the product unsterile.
The affected devices are intended for the intraoperative and transcutaneous evaluation of blood flow. The recall covers lot number 11786-37683. These products were distributed worldwide, including in the United States (specifically California), Australia, the United Kingdom, and Taiwan.
Healthcare providers and facilities should stop using the affected devices and contact Vascular Technology, Inc. for instructions on return or replacement.
The recalled product
- Product
- VTI BAYONET DOPPLER, 20MHz DOPPLER PROBE, SLIM, BX 4, REF 108660 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
- Manufacturer
- Vascular Technology, Inc.
- Category
- Medical Device — Doppler Probe
- Affected units
- 25
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 11786-37683
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.
See all 4 products in this recall →Related recalls
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