CombiSet True Flow" 2008K@home Bloodlines Fresenius Medical Care. Used for transferring blood during the hemodialysis tr
FDA device recall Z-3269-2011 · posted 2011-09-20 · Terminated
Recall details
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Reason for recall
- Blood lines coiling tabs #1 and #5 on the arterial line are not in the correct positions
- Action taken
- Fresenius Medical Care sent out an "Urgent" recall notice dated August 11, 2011 to all affected customers . The letter included description of the product name, problem and asked them to examine their stock immediately and quarantine bloodlines from the recalled lots. Customers were asked to return the product to Fresenius. For information on this recall call the Fresenius Customer Service Team at 1-800-323-5188.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- ODX
- Quantity affected
- 118 cases
- Distribution
- Nationwide Distribution.
- Date initiated
- 2011-08-11
- Date posted
- 2011-09-20
- Date terminated
- 2016-08-24
- 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 2008K @HOME WITH WIRELESS WETNESS DETECTOR (K070049) | Fresenius Medical Care North America | 2011-02-03 |