Z-0980-03

Deltec CADD-Prizm PCS II Ambulatory Infusion Pump with Revision E Software

Name: Z-0980-03 Deltec CADD-Prizm PCS II Ambulatory Infusion Pump with Revision E Software
Creator: Deltec, Inc
Published: 2003-06-23
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-06-23 / Terminated

FDA source

Deltec, Inc began a recall of Deltec CADD-Prizm PCS II Ambulatory Infusion Pump with Revision E Software on 2003-06-23. The reason FDA records is "Pump keyboard entries by the patient could have resulted in the patient having unintended access to programming screens and led to in improper drug dosage". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0980-03
Status: Terminated
Initiated: 2003-06-23
Posted: 2003-07-03
Terminated: 2004-07-02
Recalling firm: Abbott Medical
Product: Deltec CADD-Prizm PCS II Ambulatory Infusion Pump with Revision E Software
Product code: FRN Pump, Infusion
Reason for recall: Pump keyboard entries by the patient could have resulted in the patient having unintended access to programming screens and led to in improper drug dosage.
FDA root cause: Other
Action: A recall letter, sent to the consignees on June 23, stated that the firm would telephone the consignees to arrange the correction of their affected pumps by reprogramming with the new software.
Quantity in commerce: 135 pumps
Distribution: The product was distributed only to two hospitals, one in North Carolina and one in Washington State.
Product codes and lots: 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

Product code FRN

K000842Class IICadd-Prizm Pcs II Model 6101 Ambulatory Infusion SystemSims Deltec, Inc. / cleared 2000-06-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)