Recall Z-0041-2026 ยท FJI Dialyzer, Capillary, Hollow Fiber
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
| Date | Oct 3, 2025 (initiated Aug 29, 2025) |
| Status | Open, Classified |
| 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 c |
| Quantity | 172,494,732 units (14,374,561 cases @ 12 units per case) |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162488 | Optiflux dialyzer Fresenius Medical Care North America, Apr 6, 2017 |