09
Feb
2005

Baxter Healthcare Renal Division Class II

0

Company: Baxter Healthcare Renal Division
Date of Enforcement Report: 2/9/05
Class: II

PRODUCT
HomeChoice PRO Automated Peritoneal Dialysis Systems. Recall # Z-0397-05.

REASON
A software anomaly may allow concentrated solution to be infused into the patient when the HomeChoice unit is used with Physioneal Clear-Flex PD products.

CODE
Units with software version 8.7 used with Physioneal Clear-Flex PD products.

RECALLING FIRM/MANUFACTURER
Baxter Healthcare Renal Division, Mc Gaw Park, IL, by notice on December 23, 2004. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
165 units.

DISTRIBUTION
Denmark and Sweden.

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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