Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division
FDA device recall Z-0758-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Renal Div
- Reason for recall
- Microbubbles of air in the extracorporeal blood circuit during hemodialysis therapy on the Meridian.
- Action taken
- Urgent Device Correction letters dated 3/11/04 were sent to all Meridian users, informing them of adverse events associated with air in the extracorporeal blood circuit during hemodialysis therapy on the Meridian. The letter outlined the clinical practices that must be followed for all hemodialysis therapies to reduce the potential for air to be introduced into the extracorporeal blood circuit during hemodialysis. Any questions or related events to report were directed to Baxter Instrument Services at 1-800-553-6898, select prompt 3, option 2 and choice 2. Baxter developed a permanent fix -- an enhanced air detector with improved sensitivity, making it capable of detecting air bubbles of a smaller size. Letters were sent to all Meridian customers on 7/11/05, informing them of the availability of the new detector and that a Baxter Field Service Engineer would contact them to schedule the upgrade.
- Root cause
- Other
- Status
- Terminated
- Product code
- KDI
- Quantity affected
- 2,949 units
- Distribution
- Nationwide, Mexico, China and Korea.
- Date initiated
- 2004-03-10
- Date posted
- 2004-07-20
- Date terminated
- 2006-10-26
- 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 |