Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius 2008K and 20
FDA device recall Z-1325-2016 · posted 2016-04-05 · Terminated
Recall details
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Reason for recall
- Added Warning Statement: Fresenius 2008 Series Hemodialysis Machines False Blood Leak Alarm When Dialyzing Patients Treated with Hydroxocobalamin (or any form of Vitamin B-12)
- Action taken
- Fresenius Medical Care issued an Urgent Medical Device Alert dated March 10, 2016, to all affected consignees. Consignees were instructed to place notification and Warning Addendum with their 2008 Series Hemodialysis Machine Operators Manual. A reply form was included as part of the customer communication with instructions to fill out and return via fax or scanned/emailed copy. Further information or support concerning this issue, customers were instructed to contact Fresenius Technical Services at 800-227-2572.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KDI
- Quantity affected
- 8384 units (8369 US) (15 OUS)
- Distribution
- Nationwide Distribution
- Date initiated
- 2016-03-10
- Date posted
- 2016-04-05
- Date terminated
- 2017-03-09
- 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 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM (K121341) | Fresenius Medical Care North America | 2012-12-06 |
| FRESENIUS 2008T HEMODIALYSIS MACHINE (K120505) | Fresenius Medical Care North America, Design Cente | 2012-03-06 |
| FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM (K120017) | Fresenius Medical Care North America | 2012-02-02 |
| FRESENIUS 2008T HEMODIALYSIS MACHINE (K113427) | Fresenius Medical Care North America | 2011-12-21 |
| FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE (K080964) | Fresenius Medical Care North America | 2009-01-14 |