Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a hemofiltration system; Baxter H
FDA device recall Z-1338-04 · posted 2004-08-11 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Renal Div
- Reason for recall
- 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
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- KDI
- Quantity affected
- 85 units
- Distribution
- Nationwide and internationally to Belgium, China and Hong Kong
- Date initiated
- 2004-07-26
- Date posted
- 2004-08-11
- Date terminated
- 2005-11-03
- Location
- Park, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BAXTER ACCURA SYSTEM, MODEL 5M5660 (K021615) | Baxter Healthcare Corp | 2002-11-18 |