Device product
2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number: 03-2962-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
Z-0184-2014
Product summary
- Event
- Event 65739
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,528 cases
- Official record key
device-enforcement:Z-0184-2014
Official wording
Reason: Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss
Code information: All lot codes
Distribution pattern: Worldwide Distribution-USA (nationwide) and the country of Canada.
Derived failure modes
-
Unknown
Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss