Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division
FDA device recall Z-0299-05 · posted 2004-12-08 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Renal Div
- Reason for recall
- The instrument power cord may become disconnected from the instrument and pose a fire or electrical shock hazard.
- Action taken
- Baxter sent Urgent Device Correction letters dated 12/2/04 to all Meridian customers on the same date. The letters informed the accounts of the potential for disconnection of the power cord and teh potential for arcing, fire or electrical shock. The accounts were requested to examine their instruments to see if a new power cord clamp has been installed on the unit, using the enclosed instructions and complete the enclosed reply sheet indicating the number of units already corrected, and the number of units still requiring the power cord clamp. The accounts were requested to fax the completed reply for to Baxter at 847-270-5457.
- Root cause
- Other
- Status
- Terminated
- Product code
- KDI
- Quantity affected
- 3,004 units
- Distribution
- Nationwide and internationally to Mexico, China and Korea.
- Date initiated
- 2004-12-02
- Date posted
- 2004-12-08
- Date terminated
- 2006-07-21
- Location
- Park, IL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576 (K992894) | Baxter Healthcare Corp | 1999-11-24 |