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Terminated

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.

FDA Recall Z-0718-2007 · Posted 2007-04-05

Recalling FirmSmiths Medical MD, Inc.
Recall StatusTerminated
Product CodeFRN
Date Initiated2007-01-19
Date Terminated2007-05-25
Product Quantity27

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K000842CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEMSims Deltec, Inc. · 2000-06-08K973917CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP COMMUNICATIONS SYSTEMSims Deltec, Inc. · 1998-01-09K960826CADD-PRIZM MODEL 6100 PUMPSims Deltec, Inc. · 1996-08-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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