Unetixs Vascular recalls MultiLab Series II REVO non-invasive vascular diagnostic device (Model 12950-0000-01) due to risk of air embolism from misconnected IV lines.
The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
Unetixs Vascular is recalling its MultiLab Series II REVO non-invasive vascular diagnostic device because faulty luer fittings could connect the air line to an IV line, potentially causing air embolism. This recall affects all units with the specified model number and serial numbers.
The device's luer fittings and adaptors can be misconnected to intravenous lines, allowing air to enter the bloodstream. This air embolism can cause serious health complications if it reaches the bloodstream.
Healthcare professionals using the device for vascular diagnostics are most at risk. Patients receiving IV treatments may also be affected if the device is misconnected.
Check for the model number 12950-0000-01 on the device. All units with this model number and any serial number are affected by the recall.
Verify the model number on the device to confirm it is 12950-0000-01.
The device is not safe to use as recalled due to the risk of air embolism from misconnections.
The recall does not specify a remedy, so contact Unetixs Vascular directly for guidance.
Yes, misconnecting the air line to an IV line could cause air embolism, which may lead to serious health issues.
We’ve drafted a message you can send Unetixs Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1196-2023 — Unetixs Vascular Unetixs Vascular Hello, I own a Unetixs Vascular that is covered by recall Z-1196-2023 from Unetixs Vascular. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
