Recall Z-0185-2014 ยท ONW Hemodialysis System For Home Use
Fresenius Medical Care Holdings, Inc.
Combiset Blood Line with BVM for Hemodialysis use Catalog Number: 03-2965-9. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
| Date | Nov 8, 2013 (initiated Aug 29, 2013) |
| Status | Terminated |
| Reason | Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss |
| Root cause | Labeling design |
| Action | 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 |
| Quantity | 24,202 cases |
| Distribution | Worldwide Distribution-USA (nationwide) and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070049 | FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR Fresenius Medical Care North America, Feb 3, 2011 |