Medline Industries, LP has recalled specific surgical and robotic kits that contain BD SureStep Foley Tray Systems. These kits were packaged with incorrect product information insert sheets, which could lead to improper use of the device during medical procedures. Only 4 units were distributed, specifically from the LAVH MINOR kit category, although other kit types are identified in the recall.
If a mislabeled tray is used based on the incorrect instructions, patients may suffer injuries ranging from minor complications to serious conditions requiring medical intervention, such as infections or severe allergic reactions (anaphylaxis).
UDI EA: 10198459283147; UDI Case: 40198459283148
UDI EA: 10195327677329; UDI Case: 40195327677320. This was the only SKU reported as distributed (4 units).
UDI EA: 10198459164316; UDI Case: 40198459164317
UDI EA: 10198459102677; UDI Case: 40198459102678
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.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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