Recall Z-2197-2014 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Gambro Renal Products, Incorporated
Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch, 4 pouches per carton box
| Date | Aug 13, 2014 (initiated Jul 18, 2014) |
| Status | Terminated |
| Reason | Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. |
| Root cause | Device Design |
| Action | Gambro sent an Urgent Field Safety Notice dated July 18, 2014 to all end-users. A Customer Reply Form was attached to the notice for customers to complete and return. |
| Quantity | 401,451 |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032431 | PRISMA M60/M100 SETS Gambro, Inc., Sep 15, 2003 |