Product Description
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
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.
Action Details
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.
Distribution Pattern
US Nationwide distribution.
Code Information / Serial Numbers
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;
Public Record Disclaimer
This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.