The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-3026-2018·Announced 2018-09-19

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.

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 2/5 (Moderate).

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.
Category
Medical Device — Surgical Doppler
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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