Unetixs Vascular recalls MultiLab Series II 2CP and 2CP Express devices due to risk of air embolism if air line connects to IV lines. All units with model 11996-0000-01 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 2CP and 2CP Express non-invasive vascular diagnostic devices because their luer fittings could connect air lines to IV lines, potentially causing air embolism. This hazard affects users who might accidentally link the device to intravenous lines during medical procedures.
The luer fittings and adaptors on these devices can be misconnected to intravenous lines, which may allow air to enter the bloodstream. This air embolism can cause serious complications if air enters the bloodstream during medical procedures.
Users of the MultiLab Series II 2CP and 2CP Express devices who are likely to connect the air line to intravenous lines during medical procedures are most at risk. Healthcare professionals using these devices for vascular diagnostics are particularly affected.
Check for the model number 11996-0000-01 on the device. All units with this model number are affected, regardless of serial number.
Verify the model number on your device; affected units have model 11996-0000-01.
The recall states the hazard occurs when air lines are misconnected to IV lines, so it is safe if used properly without this misconnection.
Check for the model number 11996-0000-01 on the device; all units with this model are affected.
The recall does not specify a remedy, so you should check the model number and contact Unetixs Vascular if you have concerns.
We’ve drafted a message you can send Unetixs Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1193-2023 — Unetixs Vascular Unetixs Vascular Hello, I own a Unetixs Vascular that is covered by recall Z-1193-2023 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.
