Fresenius Kabi USA, LLC has recalled 14,280 IVENIX INFUSION SYSTEM LVP Blood Products Administration Sets (Model SET-0014-20). The recall is due to a mis-assembly error where the 200-micron drip chamber filter may be incorrectly positioned. This defect prevents the device from properly filtering out large blood particulates during patient administration. No injuries have been reported in connection with this issue.
If the filter is not properly positioned, large blood particles may enter the patient's bloodstream rather than being filtered out. This could lead to serious medical complications, including blockages in the blood vessels.
Intravascular Administration Set. Quantity: 14,280 units (724 cases).
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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