Recall Z-0041-2026
Fresenius Medical Care Holdings, Inc. · initiated August 29, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: 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;
Reason for recall
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-0041-2026
- Initiated
- August 29, 2025
- Posted by FDA
- October 3, 2025
- Product code
- FJI – Dialyzer, Capillary, Hollow Fiber
- Quantity
- 172,494,732 units (14,374,561 cases @ 12 units per case)
- Distribution
- US Nationwide distribution.
- Recalling firm
- Fresenius Medical Care Holdings, Inc., Waltham, MA