Mizuho Disposable Doppler Probe Recalled for Sterile Barrier Penetration
Vascular Technology, Inc. is recalling 164 Mizuho disposable Doppler probes because the sterile barrier was penetrated, potentially rendering the product unsterile.
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: The recall is classified as FDA Class II. The hazard involves a potential loss of sterility which could lead to infection, but the source text does not report any specific illnesses, injuries, or hospitalizations, placing it in the 'High' category for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Vascular Technology, Inc. is recalling 164 units of the 07-150-07 Mizuho disposable Doppler probe (Reference 138200, Lot Number 11798-37631). The recall was initiated after a report that the product's sterile barrier was penetrated. This defect could render the product unsterile, posing a risk of infection if used.
The affected devices are intended for the intraoperative and transcutaneous evaluation of blood flow. The recall covers units distributed worldwide, including the United States (specifically California), Australia, the United Kingdom, and Taiwan.
Healthcare facilities and users should stop using the affected probes immediately and contact Vascular Technology, Inc. for instructions on return or disposal. The FDA has classified this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- 07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
- Manufacturer
- Vascular Technology, Inc.
- Affected units
- 164
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 11798-37631
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
Same manufacturer · Vascular Technology, Inc.
See all →- ModerateVascular Technology Recalls 10 Mislabeled 8 MHz Surgical Doppler Transceivers
FDA (Devices) · 2018-09-19
- HighVascular Technology Recalls Sterile Doppler Probes Due to Barrier Penetration
FDA (Devices) · 2014-07-16
- HighMizuho Doppler Probe Recalled Due to Sterile Barrier Penetration
FDA (Devices) · 2014-07-16
- HighVascular Technology Recalls VTI Bayonet Doppler Probes Due to Sterility Concerns
FDA (Devices) · 2014-07-16
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