22
Apr
2010

Cl Il Baxter 1550 Single Patient System Hemodialy

0

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

About the author

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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