Optiflux 180NR Advanced Fresenius Polysulfone, Catalog No.: 0500318E, Fresenius Medical Care North America, Waltham, MA
FDA device recall Z-0738-2008 · posted 2008-02-01 · Terminated
Recall details
- Recalling firm
- Fresenius Medical Care North America
- Reason for recall
- Leaking: the Dialyzer may leak at the header resulting in small amounts of blood loss.
- Action taken
- Consignees were notified by telephone and certified letter , Urgent Device Recall, on 12/03/2007. They were told to discontinue use and to return all unused affected dialyzers to Fresenius.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KDI
- Quantity affected
- 2,791 cases (33,492 dialyzers)
- Distribution
- Nationwide including the states of AZ, CA, HI, IA, ID, IL, IN, KS, KY, MI, MN, MO, NE, NV, NY, OH, OR, PA, WA, and WI.
- Date initiated
- 2007-12-03
- Date posted
- 2008-02-01
- Date terminated
- 2008-02-08
- 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 |