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 June 30, 2005).
- Company
- Baxter Healthcare Renal Div
- Recall Initiated
- October 3, 2003
- Posted
- June 30, 2005
- Terminated
- July 1, 2005
- Recall Number
- Z-0947-05
- Quantity
- 2986 units
- Firm Location
- Mc Gaw Park, IL
- Official Source
- View on FDA website ↗
Reason for Recall
The saline bags may inappropriately empty/fill during the recirculation mode of the hemodialysis system.
Distribution
Nationwide, Korea, Mexico, Guatemala, China and Hong Kong
Lot / Code Info
all serial numbers with software version 4.0 or below
Root Cause
Other
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.
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