Company: Baxter Healthcare Corp
Date of Enforcement Report 4/21//2010
Class:ll
PRODUCT
Baxter 1550 Single Patient System Hemodialysis Machines; product codes 5M5538, 5M5538R, 5M5575, 5M5551 and 5M5551R. Recall # Z-1322-2010
REASON
Some of the 1550 Hemodialysis Instruments may have replacement circuit boards with incorrect versions of software..
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Renal Div., Mc Gaw Park, IL, by letter dated January 29, 2010.
Manufacturer: Baxter Healthcare Corp., Largo, FL. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
443 boards
DISTRIBUTION
Nationwide, Argentina, Brazil, Canada, Chile, China, Colombia, Ecuador, Guatemala, Honduras, Mexico, Panama, Philippines, Romania, Turkey and Venezuela
