Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division
FDA device recall Z-0947-05 · posted 2005-06-30 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Renal Div
- Reason for recall
- The saline bags may inappropriately empty/fill during the recirculation mode of the hemodialysis system.
- Action taken
- No official recall notificaiton was made. Meridian software version 4.12 was released on 10/3/03 and was implemented as a reliability improvement initiative to all Meridian customers. Shipment of 4.12 software was completed in November 2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- KDI
- Quantity affected
- 2986 units
- Distribution
- Nationwide, Korea, Mexico, Guatemala, China and Hong Kong
- Date initiated
- 2003-10-03
- Date posted
- 2005-06-30
- Date terminated
- 2005-07-01
- 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 |
|---|---|---|
| MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576 (K992894) | Baxter Healthcare Corp | 1999-11-24 |