Optiflux Series Fresenius Polysulfone F160NR dialyzer High Flux Catalog Number: 0500316N
FDA device recall Z-0333-06 · posted 2005-12-31 · Terminated
Recall details
- Recalling firm
- Fresenius Medical Care North America
- Reason for recall
- Mislabeled: Inner product mislabeled as F180NR (Catalog Number 0500318N) instead of F160NR
- Action taken
- Fresenius Medical notified consignees by letter dated 11/28/05 sent Certified Mail on 11/29/05 requesting return of product inventory.
- Root cause
- Other
- Status
- Terminated
- Product code
- KDI
- Distribution
- Nationwide
- Date initiated
- 2005-11-28
- Date posted
- 2005-12-31
- Date terminated
- 2006-08-10
- Location
- Lexington, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FRESENIUS OPTIFLUX 200NR (K002277) | Fresenius Medical Care North America | 2000-08-25 |