Cl Il System 1000 family of Hemodialysis Instrume

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

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.