Vascular Technology Recalls 10 Mislabeled 8 MHz Surgical Doppler Transceivers
Vascular Technology, Inc. is recalling 10 surgical Doppler transceivers that may be mislabeled as 20 MHz units instead of 8 MHz units.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a minor labeling error regarding frequency specifications without reported injuries or illnesses, fitting the Moderate severity criteria.
Plain-English summary
Vascular Technology, Inc. is recalling 10 units of the VTI 8 MHz Surgical Doppler Transceiver, Reference Number 108910. The recall is due to a labeling error where the devices may be mislabeled as 20 MHz Doppler transceivers instead of the correct 8 MHz specification.
The affected units were distributed in the United States to the state of California. The specific serial numbers for the recalled units are 14329-001 through 14329-010. These devices are intended for intraoperative, transesophageal, transrectal, laparoscopic, and peripheral vascular use.
Healthcare providers and consumers should check their inventory for these specific serial numbers. If a unit is found, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority for further instructions.
The recalled product
- Product
- VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910 Intraoperative (microvascular and vascular), Intraoperative Neurological, Transesophageal, Transrectal, Laparoscopic and Peripheral Vascular.
- Manufacturer
- Vascular Technology, Inc.
- Hazard
- Affected units
- 10
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 (10)
- Serial Numbers: 14329-001
- 14329-002
- 14329-003
- 14329-004
- 14329-005
- 14329-006
- 14329-007
- 14329-008
- 14329-009
- and 14329-010.
Distribution
Distributed in 1 state:
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