Dialyzer Optiflux 160NRe
FDA device recall Z-0801-2025 · posted 2025-01-03 · Open, Classified
Recall details
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Reason for recall
- Potential for internal blood leaks due to cracked polyurethane
- Action taken
- Fresenius Medical Care notified consignees on about 12/05/2024 via URGENT MEDICAL DEVICE RECALL letter. Consignees were instructed to stock immediately for either of the affected lot numbers, immediately discontinue use of Optiflux F160NRe Dialyzer(s) with lot codes, place any of the affected units in a secure, segregated area, arrange for return of affected product and complete and return the provided Reply Form. Additionally, consignees were instructed to forward the notification to any personnel within the organization or to customers where product was further distributed.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- KDI
- Quantity affected
- 5,351 cases (64,212 dialyzers)
- Distribution
- Nationwide Distribution.
- Date initiated
- 2024-12-05
- Date posted
- 2025-01-03
- Location
- Waltham, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Optiflux dialyzer (K162488) | Fresenius Medical Care North America | 2017-04-06 |