Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A.
This recall has been terminated (originally issued December 8, 2004).
- Company
- Baxter Healthcare Renal Div
- Recall Initiated
- December 2, 2004
- Posted
- December 8, 2004
- Terminated
- July 21, 2006
- Recall Number
- Z-0299-05
- Quantity
- 3,004 units
- Firm Location
- Mc Gaw Park, IL
- Official Source
- View on FDA website ↗
Reason for Recall
The instrument power cord may become disconnected from the instrument and pose a fire or electrical shock hazard.
Distribution
Nationwide and internationally to Mexico, China and Korea.
Lot / Code Info
serial numbers 200101 to 202190
Root Cause
Other
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.