FDA Medical Device Recalls (openFDA)
Fresenius Medical Care Holdings, Inc.: 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
- Recall number
- Z-0041-2026
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- 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
- Status
- Open, Classified
- Initiated
- 2025-08-29
- Posted
- 2025-10-03
- Terminated
- not on file
- Reason
- 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
- Device Design
- Action
- 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.
- Quantity
- 172,494,732 units (14,374,561 cases @ 12 units per case)
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- 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;
- 510(k) numbers
- ["K162488"]
- PMA numbers
- not on file
- Product code
- FJI
- Firm FEI
- 3001451489
- Firm city
- Waltham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28