Company: Baxter Healthcare Renal Div,
Date of Enforcement Report: 7/13/05
Class: III

PRODUCT
Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R, Recall # Z-0947-05

REASON
The saline bags may inappropriately empty/fill during the recirculation mode of the hemodialysis system.

CODE
All serial numbers with software version 4.0 or below

RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Renal Div, McGaw Park, IL, no official recall notification 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.
Manufacturer: Baxter Healthcare Corporation, Largo, FL. Firm initiated recall is complete

VOLUME OF PRODUCT IN COMMERCE
2986 units

DISTRIBUTION
Nationwide, Korea, Mexico, Guatemala, China and Hong Kong