Jul

2003

Inc Class II Deltec

Company: Deltec, Inc.
Date of Enforcement Report: 7/23/03
Class: II

PRODUCT
Deltec CASS-Prizm PCS II Ambulatory Infusion Pump with Revision E Software. Recall # Z-0980-03.

REASON
Pump keyboard entries by the patient can result in the patient having unintended access to programming screens and result in improper drug dosage.

CODE
Pump Serial numbers 658825, 658837, 658840, 658842,
658844 – 658865, 658867, 658869 – 658896, 658898 – 658918, 658920 – 658936, 658941, 658943 – 658947, 658949,
662473 – 662477, 662483, 662485, 662488 – 662490, and 662635 – 662659.

RECALLING FIRM/MANUFACTURER
Deltec, Inc., St. Paul, MN, by letter on June 23, 2003. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
135 pumps.

DISTRIBUTION
NC, and WA.

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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