Oct

2005

Baxter Healthcare Corp. Class II

Company: Baxter Healthcare Corp.
Date of Enforcement Report: 10/26/2005
Class:II

PRODUCT
Baxter’s Patient Care System (BPCS) software, Pharmacy Management – Inpatient – product code 2M5013 and Point of Care – product code 2M5014; made in Canada, Recall # Z-0061-06

REASON
If an administrative user modifies any of the seven pre-defined Monitoring Parameters when they are attached to a medication in the drug file, a Point of Care end user will be unable to enter monitoring parameter results on the handheld.

CODE
All units of software versions 4.0 (66) and 4.1 (77)

RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated August 29, 2005.

Manufacturer: Baxter Healthcare Corp/Patient Care System, Toronto, Canada. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
MO, MA, VT, CA and Canada

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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Baxter Healthcare Corp. Class II

Amy Sellers

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