Optiflux F180NR Dialyzers, Catalog Number: 0500318E. Manufactured by Fresenius Medical Care North America, Ogden, UT 844
FDA device recall Z-1951-2010 · posted 2010-07-01 · Terminated
Recall details
- Recalling firm
- Fresenius Medical Care North America
- Reason for recall
- Hemodialyzer may leak at the header/end cap
- Action taken
- Fresenius Medical notified customers by telephone script beginning May 14, 2010 and follow up letter advising users to examine inventory for recalled lot, discontinue use and contact Fresenius Customer Care 1-800-325-5188 , ext. 6610 for instructions on how to return the recalled product.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KDI
- Quantity affected
- 34,152 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2010-05-14
- Date posted
- 2010-07-01
- Date terminated
- 2011-09-13
- Location
- Waltham, 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 |