The Recall Desk
HighFDA (Devices)·Z-1195-2023·Announced 2023-03-08

Vascular Diagnostic Device Recalled for Risk of Air Line Misconnection

Unetixs Vascular recalls MultiLab Series II ROODRA vascular diagnostic devices due to luer fittings that may allow air line misconnection to intravenous lines, potentially causing air embolism.

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: This is an FDA Class II recall of a medical device with potential for serious harm (air embolism). No illnesses or injuries have been reported in the source text. Per the severity rubric, risk-of-harm products where injury has not yet been reported are classified as High (score 3).

Plain-English summary

Unetixs Vascular, Inc. is recalling the MultiLab Series II ROODRA non-invasive vascular diagnostic device (Model 11986-0000-01). The device's luer fittings and adaptors may allow the air line to be misconnected to an intravenous line, which could cause an air embolism.

Approximately 2,000 units have been distributed worldwide, including throughout the United States. All serial numbers of Model 11986-0000-01 are affected by this recall.

The FDA classified this as a Class II recall of this vascular diagnostic device. The hazard identified is the potential for unintended connection of the air line to intravenous lines during use.

The recalled product

Product
MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01
Manufacturer
Unetixs Vascular, Inc.
Category
Medical Device — Vascular Diagnostic
Hazard
  • air-embolism
  • line-misconnection

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)

  • All Serial Numbers

Distribution

Distributed nationwide across the United States.

Related recalls

Same category