May

2003

Abbott Laboratories Class II

Company: Abbott Laboratories, Inc
Date of Enforcement Report: 5/28/03
Class: II

PRODUCT
a) Gemstar_ 7 Therapy I.V. Infusion Pump, List#: 13000-04; 2.9
Software Version. Recall # Z-0792-03;
b) Gemstar_ 6 Therapy I.V. Infusion Pump, List#: 13100-04; 2.9
Software Version. Recall # Z-0793-03;
c) Gemstar_ Therapy Pain Management I.V. Infusion Pump,
List#: 13150-04; 2.9 Software Version. Recall # Z-0794-03;

REASON
Products contain software deficiencies which could allow over infusion thereby administering excess medication.

CODE
All serial numbers.

RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Morgan Hill, CA, by letters on April 1, 2003. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1,310 units.

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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Abbott Laboratories Class II

Amy Sellers

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