Recall Z-1338-04 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
| Date | Aug 11, 2004 (initiated Jul 26, 2004) |
| Status | Terminated |
| Reason | The Accura machine display screen may go blank during patient treatment. There is a potential risk to the patient in that the operator may try to manipulate the controls in response to a blank screen, which could affect the current patient's treatment |
| Root cause | Other |
| Action | Baxter sent an Urgent Device Correction letter dated 7/26/04 to the direct accounts on the same date, to the attention of the Hemodialysis Unit and Hospital Administrator. The letters informed the accounts of the potential problem and provided instructions on the procedure to follow in the event the screen goes blank during patient use. Any questions were directed to Baxter Instrument Services at 1-800-553-6898, select prompt 3, option 4. |
| Quantity | 85 units |
| Distribution | Nationwide and internationally to Belgium, China and Hong Kong |
| 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 |