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.
