Company:Baxter Healthcare Renal Division
Date of Enforcement Report 12/3/2009
Class:ll
PRODUCT
System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and AltraTouch; The Hemodialysis and Continuous Renal Replacement Therapy devices are used for acute and chronic hemodialysis, including high flux hemodialysis. The device is intended for use by trained operators when prescribed by a physician. The device is intended to be used with hollow fiber or parallel plate dialyzers. Recall # Z-0179-2010
REASON
When the main power is lost temporarily, a software anomaly prevents the instrument from automatically changing the ultra filtration rate (UFR) to the minimum value as described in the Operator’s manual.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Renal Division, McGaw Park, IL, by letter dated August 31, 2009.
Manufacturer: Baxter Healthcare Corp., Largo, FL. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
8,258 units
DISTRIBUTION
Nationwide including Puerto Rico and the Virgin Islands, and internationally
