BEUDAMED
    FDA Recall Terminated

    CADD Medication Cassette Reservoir 100 ml with Clamp and Female Leur, Nonvented stopper included REF 21-7002-24, Sterile EO. CADD Medication Cassette Reservoirs are intended for use with the CADD Ambulatory Infusion Pumps used for delivering drug therapy and anesthesia to patients. The pumps can be used by home care patients and in a healthcare facility.

    Recall: Z-0987-2009 · Initiated December 9, 2008

    Recall

    Recall Number
    Z-0987-2009
    Event Number
    50829
    Firm
    Smiths Medical MD, Inc.
    FEI Number
    2183502
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 9, 2008
    Posted
    April 20, 2009
    Terminated
    June 7, 2012
    Address
    1265 Grey Fox Rd, Saint Paul, MN, 55112-6929

    Description

    CADD Medication Cassette Reservoir 100 ml with Clamp and Female Leur, Nonvented stopper included REF 21-7002-24, Sterile EO. CADD Medication Cassette Reservoirs are intended for use with the CADD Ambulatory Infusion Pumps used for delivering drug therapy and anesthesia to patients. The pumps can be used by home care patients and in a healthcare facility.

    Reason

    Smiths Medical noticed an increased trend in leakage associated with 100 ml CADD Medication Cassette Reservoirs Reorder Number 21-7002-24 Lot Numbers 213X18 and 214X18. If a leak occurs in a CADD medication Cassette Reservoir, it may allow spillage of medication, contamination of the fluid path, and/or air to enter the Reservoir. Smiths Medical has not received any report of patient injuries due

    Action

    An "Urgent Medical Device Recall" letter was sent via electronic mail to consignees on December 8, 2008. The letter was addressed to Distributors, Clinicians and other Customers. The letter described the problem and affected product and listed the "Advise on Action to be Taken by the User". Smiths Medical MD, Inc. requested the user to complete and return the "Urgent Medical Device Recall Confirmation Fax Return Form" and fax to the firm at 1-651-628-7485 or e-mail to [email protected] (in US) or [email protected] (outside US). Direct questions to the Smiths Medical MD, Inc. Customer Service Department at 1-800-426-2448, Option 1.

    Distribution

    Worldwide Distribution USA (state of PA) and countries of El Salvador, Australia, France, Finland, Sweden, and Germany.

    Quantity

    17,868 cassettes (1,489 boxes 12 cassettes/box)