BEUDAMED
    FDA Recall 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.

    Recall: Z-0718-2007 · Initiated January 19, 2007

    Recall

    Recall Number
    Z-0718-2007
    Event Number
    37486
    Firm
    Smiths Medical MD, Inc.
    FEI Number
    2183502
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 19, 2007
    Posted
    April 5, 2007
    Terminated
    May 25, 2007
    Address
    1265 Grey Fox Rd, Saint Paul, MN, 55112-6929

    Description

    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.

    Reason

    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.

    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.

    Distribution

    Nationwide.

    Quantity

    27