Unetixs Vascular recalls MultiLab Series II ROODRA non-invasive vascular diagnostic device (Model 11986-0000-01) due to risk of air embolism from misconnected IV lines. All units with serial numbers are affected.
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 ROODRA non-invasive vascular diagnostic device because improper connections could cause air embolism. This is serious as air embolism can be life-threatening if it enters the bloodstream.
The luer fittings and adaptors on the device can connect incorrectly to intravenous lines. This misconnection allows air to enter the bloodstream, potentially causing an air embolism which can be life-threatening.
Patients using this device for vascular diagnostics are at risk. Healthcare providers who use the device for medical assessments may be affected.
Check for the MultiLab Series II ROODRA device with model number 11986-0000-01. All units have serial numbers that need to be verified.
Immediately stop using the MultiLab Series II ROODRA device if it has been connected to an intravenous line.
The device is not safe to use as it poses a risk of air embolism if misconnected to an IV line.
Stop using it immediately and contact Unetixs Vascular for further instructions.
Check the model number (11986-0000-01) and serial number on the device. All units are affected.
We’ve drafted a message you can send Unetixs Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1195-2023 — Unetixs Vascular Unetixs Vascular Hello, I own a Unetixs Vascular that is covered by recall Z-1195-2023 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.
