03

Dec

2009

Cl Il System 1000 family of Hemodialysis Instrume

0

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

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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