Recall Z-0695-2007 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Gambro Renal Products, Inc.
Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Gambro Lundia AB, Sweden.
| Date | Mar 31, 2007 (initiated Jan 4, 2007) |
| Status | Terminated |
| Reason | Under certain conditions, * an excessive amount of anticoagulant may be infused into the patient. (* interruption of a self-test by an alarm and obstruction of the access lines) |
| Root cause | Device Design |
| Action | Customers were notified by letter on 12/19/2006. They were told that Gambro would schedule the required upgrades to their equipment and not to use the current syringe for delivering anticoagulant. |
| Quantity | 153 units (Domestic) |
| Distribution | Nationwide distribution -- including states of AL, CA, FL, GA, IN, MD, ME, MI, MS, NC, NH, NY, OH, PA, SC, TX, VA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041005 | GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS Gambro Renal Products, Oct 7, 2004 |