Unetixs Vascular recalls MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic devices due to potential air embolism risk from misconnected IV lines. Affected units have model number 11949-0000-01 and all serial numbers.
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 LHS TI & ERGO non-invasive vascular diagnostic devices because the luer fittings could connect the air line to an IV line, potentially causing air embolism. This risk affects users who may have the device in their home or medical settings.
The device's luer fittings and adaptors can be misconnected to intravenous lines, which may allow air to enter the bloodstream as an air embolism. This can happen if the air line is accidentally attached to an IV line during use, creating a serious health risk.
Users of the MultiLab Series II LHS TI & ERGO device, particularly those in home medical settings or healthcare environments, are most at risk due to the potential for air embolism if the device is misconnected to an IV line.
Check for the model number 11949-0000-01 on the device. All units with this model number and any serial number are affected by this recall.
Verify the model number on the device to confirm it is 11949-0000-01.
The recall record does not mention any remedy or fix for this issue.
Check for the model number 11949-0000-01 on the device; all units with this model number and any serial number are affected.
The recall record does not specify any action steps for affected users.
We’ve drafted a message you can send Unetixs Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1194-2023 — Unetixs Vascular Unetixs Vascular Hello, I own a Unetixs Vascular that is covered by recall Z-1194-2023 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.
