—#215902

Product

Optiflux High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, (4) 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM

FDA product code: FJI — Dialyzer, Capillary, Hollow Fiber
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K162488
Affected lot / code info: 1. Model: 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, UDI-DI: 840861100149, All Lots manufactured after SEP/06/2023, 2. Model: 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, UDI-DI: 840861100156, All Lots manufactured after SEP/06/2023, 3. Model: 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, UDI-DI: 840861100163, All Lots manufactured after SEP/06/2023, 4. Model: 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM, UDI-DI: 840861100170, All Lots manufactured after SEP/06/2023;

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

On August 29, 2025 IMPORTANT MEDICAL DEVICE INFORMATION letters were sent to customers. Actions to be taken: 1. Follow the New Instructions for Use provided in this letter when attaching the dialyzer caps. 2. Please report any complaints or adverse events to product.complaints@fmcna. com or FDA MedWatch at https://www.fda.gov/safety/medical-product-safetyinformation/ medwatch-forms-fda-safety-reporting. 3. Please forward this notice to any providers who may have received these products from you. Place this notification with the device to ensure awareness. For product technical questions or concerns, please contact the Technical Support at 1- 800-323-2732 or Customer Support at 1-800-323-5188. For any clinical or medical questions, please contact the Global Medical Information and Education Office at 1-855- 616-2309. This notification serves as important medical device information. FMCRTG is not requesting the return of any product. FMCRTG is working diligently to provide the updated Instructions for Use with the product and expects release in Q4 2025. The health and safety of your patients continue to be our highest priority. Thank you for your cooperation.

Recalling firm

Firm: Fresenius Medical Care Holdings, Inc.
Address: 920 Winter St, Bld 920, Waltham, Massachusetts 02451-1521

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2025-08-29
Posted by FDA: 2025-10-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #215902. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.