BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0980-03 · Initiated June 23, 2003

    Recall

    Recall Number
    Z-0980-03
    Event Number
    26550
    Firm
    Deltec, Inc
    FEI Number
    2183502
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 23, 2003
    Posted
    July 3, 2003
    Terminated
    July 2, 2004
    Address
    1265 Grey Fox Road, St Paul, MN, 55112

    Description

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

    Reason

    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.

    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.

    Distribution

    The product was distributed only to two hospitals, one in North Carolina and one in Washington State.

    Quantity

    135 pumps