Fresenius Medical Care Holdings, Inc. is recalling 5,351 cases (approximately 64,212 units) of its Dialyzer Optiflux 160NRe because the polyurethane material in the device can crack. These cracks may lead to internal blood leaks during medical procedures. While no injuries have been reported, the defect affects products with UDI numbers 24HU06011-00840861100149-270630 and 24HU06010-00840861100149-270630 and an expiration date of June 30, 2027.
Cracked polyurethane in the dialyzer can cause internal blood leaks during dialysis treatment, potentially resulting in blood loss or exposure to contaminants. There are currently no reports of incidents or injuries related to this defect.
Quantity: 5,351 cases (64,212 dialyzers) affected.
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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