Recall Z-1380-05 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Baxter Healthcare Renal Div
Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a hemofiltration system; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085, manufactured in Germany
| Date | Aug 18, 2005 (initiated Jul 13, 2005) |
| Status | Terminated |
| Reason | In the event therapy is terminated, as part of routine instrument programming or therapy maintenance, the Accura instrument may experience difficulty in performing a successful self-test (failure) upon an immediate attempt to restart therapy |
| Root cause | Device Design |
| Action | Baxter sent Important Product Information letters dated 7/13/05 to all Accura device customers, to the attention of the Director of Nursing, via first class mail. The letter informed the accounts of the on-going investigation into the potential self-test failure associated with the Accura instrument, and provided the customers with steps to follow if they encounter failed instrument self-tests. These guidance steps include: 1) Place the instrument into 'stand-by' mode. Generally, 15 minutes in 'stand-by' mode is sufficient to allow successful instrument self-test procedures. Enter 'stand- |
| Quantity | 264 units |
| Distribution | Nationwide and internationally to China and Belgium |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021615 | BAXTER ACCURA SYSTEM, MODEL 5M5660 Baxter Healthcare Corp, Nov 18, 2002 |