Med Michigan Holding Llc has recalled approximately 109 boxes (2,180 units) of SUC-4300S Rigid Intracardiac Sucker Fluted Tip devices. These handheld surgical tools, used to remove excess fluid during operations, were found to have incomplete or partial seals on their sterile packaging pouches. No injuries or medical incidents have been reported to date.
A breach in the sterile pouch seal can allow contaminants to enter the packaging, compromising the sterility of the device. Using a non-sterile device during an intracardiac procedure poses a significant risk of infection or other serious complications for the patient.
Indicated for handheld use only to remove excess fluid from the surgical field.
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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