Fresenius Medical Care Holdings recalled over 172 million dialyzers on August 29, 2025. The recall affects models with a new cap design that may not securely attach. Healthcare providers and patients must stop using these devices immediately.
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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The recall includes four models of the Optiflux High Flux E-beam Dialyzer: 0500316E, 0500318E, 0500320E, and 0500325E. Each model is packaged in cases of 12 units, totaling 172,494,732 units distributed across the U.S. after September 6, 2023.
The dialyzers have undergone a design change, replacing threaded caps with press-on caps. Users may not properly secure the cap, leading to potential device malfunction during treatment.
There have been no reported injuries or deaths associated with this recall. The high hazard level indicates a serious risk of improper device use.
Patients and healthcare providers must stop using the affected dialyzers immediately. Contact Fresenius Medical Care Holdings, Inc. or your healthcare provider for instructions and follow the recall guidelines.
For more information, visit the FDA website or contact Fresenius Medical Care Holdings, Inc. at the provided contact number.
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