Fresenius Medical Care Holdings, Inc. is recalling 172,494,732 units (14,374,561 cases) of Optiflux High Flux E-beam Dialyzers because the product caps were changed from a threaded version to a press-on version. If users do not press the caps firmly onto the dialyzer, they may not be securely attached. This recall affects various models of the Optiflux E-beam series manufactured after September 6, 2023, and aims to provide users with the correct information to ensure proper securement during use.
If the caps are not pressed firmly onto the dialyzer as required by the new design, the device may not be securely sealed. This could lead to improper functioning of the medical device or potential leakage during treatment, which may compromise patient safety.
Information and securement instructions
Recall #: Z-0041-2026; Quantity: 172,494,732 total units across all models.
Recall #: Z-0041-2026
Recall #: Z-0041-2026
Recall #: Z-0041-2026
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.
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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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