BEUDAMED
    FDA Recall Terminated

    Smiths Medical, CADD-Solis Ambulatory Infusion Pump, Model Number: 2100 and 2110, Reorder Number 21-2101-00, 21-2101-0100-50, 21-2101-0100-51, 21-2101-0200-02, 21-2101-0200-03, 21-2111-0100-51, 21-2111-0200-02, and 21-2102-51.

    Recall: Z-1033-2011 · Initiated January 13, 2011

    Recall

    Recall Number
    Z-1033-2011
    Event Number
    57650
    Firm
    Smiths Medical ASD, Inc.
    FEI Number
    2183502
    Product Code
    MEA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 13, 2011
    Posted
    February 3, 2011
    Terminated
    April 17, 2012
    Address
    1265 Grey Fox Rd, Saint Paul, MN, 55112-6929

    Description

    Smiths Medical, CADD-Solis Ambulatory Infusion Pump, Model Number: 2100 and 2110, Reorder Number 21-2101-00, 21-2101-0100-50, 21-2101-0100-51, 21-2101-0200-02, 21-2101-0200-03, 21-2111-0100-51, 21-2111-0200-02, and 21-2102-51.

    Reason

    Reports of the Cassette Lock mechanism on certain CADD-Solis Pumps becoming stuck in the locked position, making it nearly impossible to remove the medication cassette reservoirs (or administration set). The purpose of the Cassette Lock is to secure the medication cassette reservoir (or administration set) to the pump.

    Action

    The firm, Smiths Medical, sent an "URGENT MEDICAL DEVICE CORRECTION NOTICE" dated January 13, 2011 to all consignees/customers. The notice described the product, problem, and action to be taken by the customers. The customers were instructed to have their Pumps undergo a correction which consist of removal and reattachment of the Cassette Latch handle using a new adhesive process. The customers were also instructed to remove the Pump from service if unable to remove cassette (or administration set); to inspect their inventory and identify Pumps; prepare a plan for correction of these Pumps; complete and return the attached CONFIRMATION FORM via fax to 1-800-237-8033 or by email to [email protected], and if they have distributed the affected product to other persons or facilities, promptly forward this notice to the recipients. If you should have any questions regarding this information, please contact Smith Medical at 1-866-216-8806.

    Distribution

    Worldwide Distribution: USA including states of: AK, AZ, C, CO, DC, FL, GA, ID IL, MA, MI, MN, MO, MT, NE, NH, NM, NY, NC, OK, OR, PA, RI, TN, TX, UT, VT, VA, WA, WI, and WY; and countries including: Australia, Austria, Belgium, Canada, France, Germany, Great Britain, Ireland, Italy, Luxembourg, New Zealand, Qatar, Saudi Arabia, Switzerland and The Netherlands.

    Quantity

    2903 (2539 US; 364 OUS)