Z-0718-2007

Deltec branded CADD-Prizm PCS II ambulatory infusion pump and the CADD-Prizm VIP system ambulatory infusion...

Name: Z-0718-2007 Deltec branded CADD-Prizm PCS II ambulatory infusion pump and the CADD-Prizm VIP system ambulatory infusion...
Creator: Smiths Medical MD, Inc.
Published: 2007-01-19
License: https://open.fda.gov/license/

Abbott Medical / initiated 2007-01-19 / Terminated / root cause: software

FDA source

Smiths Medical MD, Inc. began a recall of Deltec branded CADD-Prizm PCS II ambulatory infusion pump and the CADD-Prizm VIP system ambulatory infusion pumps; (Both) Model 6101; Order #21-8861-01 (PCS... on 2007-01-19. The reason FDA records is "The year of manufacture had been incorrectly entered as 1980 into the pumps software during the manufacture process. As a result the pump may go into an immediate 'Clock battery is Low/Service Immediately' or 'Clock...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0718-2007
Status: Terminated
Initiated: 2007-01-19
Posted: 2007-04-05
Terminated: 2007-05-25
Recalling firm: Abbott Medical
Product: Deltec branded CADD-Prizm PCS II ambulatory infusion pump and the CADD-Prizm VIP system ambulatory infusion pumps; (Both) Model 6101; Order #21-8861-01 (PCS II) and 21-8821-01 (VIP). Smiths Medical MD, Inc., St. Paul, MN 55112 USA; RX ONLY.
Product code: FRN Pump, Infusion
Reason for recall: The year of manufacture had been incorrectly entered as 1980 into the pumps software during the manufacture process. As a result the pump may go into an immediate 'Clock battery is Low/Service Immediately' or 'Clock Battery needs service soon' alarm message indicating that the pump requires servicing.
Root cause tag: software
FDA root cause: Other
Action: All consignees who have received the affected CADD-Prizm PCS II ambulatory infusion pumps and the CADD-Prizm VIP System ambulatory infusion pumps were contacted via telephone by February 1, 2007. The problem will be explained to the consignee and they will be asked to return the pumps to Smiths Medical MD in order for the problem to be corrected.
Quantity in commerce: 27
Distribution: Nationwide.
Product codes and lots: Serial numbers affected: 691099, 691108, 691117, 691700, 691704, 691713, 691719, 691724, 691729, 691731, 691734, 691737, 691739, 691744, 691748, 691756, 691761, 691764, 691769, 691772, 691776, 691780, 691785, 691788, 691793, 691794, 691798.

Product code FRN

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)