May

2003

Inc. Class II Deltec

Company: Deltec, Inc.
Date of Enforcement Report: 5/28/03
Class: II

PRODUCT
Deltec Cozmo Insulin Pump, Model 1700, Product Catalog Numbers 21-1711-01, 21-1712-01 and 21-1713-01. The 3 versions vary only in the color of the exterior.
Recall # Z-0798-03.

REASON
A software error can result in the delivery of a larger bolus of insulin than anticipated when the pump is programmed in a particular manner.

CODE
All units distributed since product introduction in December 2002 are involved.

RECALLING FIRM/MANUFACTURER
Deltec, Inc., St Paul, MN, by letters on March 14, 2003. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
913 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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Inc. Class II Deltec

Amy Sellers

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