08

Feb

2008

Cl II Baxter Healthcare Renal Division

0

Company: Baxter Healthcare Renal Division
Date of Enforcement Report 2/6/2008
Class:ll

PRODUCT
Baxter RenalSoft v.2.0 Patient Management Software Suite – HD Module;
clinical data management software, Recall # Z-0527-2008;
b) Baxter Renal Software Suite v.3.0 and v.3.1 – Renal Link HD Module; clinical data
management software; Recall # Z-0528-2008

REASON
Pre-Treatment/Post-Treatment Report errors: 1) The Heparin Bolus Value is displayed on Pre and Post Treatment Reports for patients with “No Heparin” orders (RenalSoft v2.0, Renal Software Suite v.3.0 and v.3.1), and 2) Withheld Medications are incorrectly displayed as Administered on the Pre-Treatment report (RenalSoft v.2.0 only).

RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Renal Division, McGraw Park, IL, by letter, dated November 14, 2007.
Manufacturer: Baxter Healthcare Corporation, Largo, FL. Firm initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
73 units

DISTRIBUTION
Nationwide 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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