Combiset Blood Line Hemodialysis use Catalog Number: 03-2622-3. Intended for use as the extracorporeal blood circuit dur
FDA device recall Z-0186-2014 · posted 2013-11-08 · Terminated
Recall details
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Reason for recall
- Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss
- Action taken
- Fresenius issued a Field Notification Letter dated 8/29/13 to Patient Clinics/ associated at home patients and provides additional detail instructions to ensure the connection to the transducer protector bloodline female luer interface is secure. This field advisory notice sent by Certified Mail, Return Receipt Requested. Accounts requested to return both the receipt and the completed reply form (enclosed) to confirm receipt of the notice. If you have any questions regarding this field advisory, please contact FMCNA Customer Service Team at 1-800-323-5188. Customer Service will be available Monday-Friday 7am-6pm CST.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- ONW
- Quantity affected
- 508,029 cases
- Distribution
- Worldwide Distribution-USA (nationwide) and the country of Canada.
- Date initiated
- 2013-08-29
- Date posted
- 2013-11-08
- Date terminated
- 2021-02-11
- 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 |