Recall Z-1901-2011 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Gambro Renal Products, Incorporated
Prismaflex System, Catalog Number 107493, Indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload.
| Date | Apr 6, 2011 (initiated Mar 14, 2011) |
| Status | Terminated |
| Reason | Prismaflex touch screen may become unresponsive during Continuous Renal Replacement Therapy procedure. |
| Root cause | Software change control |
| Action | The firm, GAMBRO Renal Products, sent an "URGENT - MEDICAL DEVICE RECALL" letter dated March 14, 2011 to all customers. The letter described the product, problem and actions to be taken. The customers were provided with response procedures to use if the frozen screen problem occurs while using the product. The customers were instructed to closely monitor the return line for potential air and/or clots in the circuit; review the instructions provided in the attached copy of Chapter 5: Troubleshooting, "Softkeys won't work." of the Prismaflex Operators Manual in conjunction with the attached Tro |
| Quantity | 1300 units |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072093 | PRISMAFLEX SYSTEM, VERSION 3.20 Gambro, Feb 1, 2008 |