Jul

2002

Baxter Healthcare Corp Class II

Company: Baxter Healthcare Corp
Date of Enforcement Report: 7/31/02
Class: II

PRODUCT
Baxter Ipump Pain Management System infusion pump, product codes 2L3107 and 2L3107R, Baxter Healthcare Corporation, Deerfield, IL. Recall # Z-1166-2.

REASON
Software anomaly allows access to change prescription or program bolus without security.

CODE
Product codes 2L3107 and 2L3107R, all serial numbers.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated April 10, 2002.
Manufacturer: Baxter Healthcare Pte. Ltd., Singapore, SG. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
9,927 pumps.

DISTRIBUTION
Nationwide.

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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