Fresenius Medical Care recalls 172,494,732 Optiflux High Flux E-beam Dialyzers distributed nationwide in the United States. Caps on these dialyzers were changed from threaded to press-on versions, requiring users to press the caps firmly to secure them. Patients and healthcare providers should stop using these devices immediately and follow recall instructions issued by the manufacturer.
To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Fresenius Medical Care Holdings, Inc. or your healthcare provider for instructions. Notification method: Letter
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Optiflux High Flux E-beam Dialyzers are used in hemodialysis to remove waste products from the blood. They are sold to healthcare providers and facilities for patient treatment.
The recall centers on a cap design issue. A shift from threaded to press-on caps requires firm pressing to secure. If not secured properly, there could be device integrity concerns.
This recall is not stated as part of a broader industry pattern.
The recall affects a large stock likely used in dialysis centers. The immediate impact is operational shutdown of affected devices until replacement guidance is provided.
Refer to the FDA recall page and Fresenius Medical Care’s recall communications for model-specific guidance.
Replacement or refund options are processed after manufacturer instructions are issued. Typical timelines range from several weeks to a couple of aix.
Keep the recall letter, model numbers, purchase documentation, and all correspondence with the manufacturer and healthcare providers.
Model numbers: 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM; 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM; 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM; 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM. Distribution: US nationwide. Quantity: 172,494,732 units (14,374,561 cases @ 12 units per case). Recall date: 2025-08-29. Recall status: ACTIVE.
No injuries or incidents have been reported.
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