BEUDAMED
    FDA Recall Terminated

    Smiths Medical, CADD-Solis ambulatory infusion pumps, Models 2100, REF 21-2101-0200-51 and 2110, REF 21-2111-0100-51, Rx Only. Indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/ surgical wound site), epidural space, or subarachnoid space infusion.

    Recall: Z-0004-2012 · Initiated May 10, 2011

    Recall

    Recall Number
    Z-0004-2012
    Event Number
    58823
    Firm
    Smiths Medical ASD, Inc.
    FEI Number
    2183502
    Product Code
    MEA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 10, 2011
    Posted
    October 4, 2011
    Terminated
    July 19, 2012
    Address
    1265 Grey Fox Rd, Saint Paul, MN, 55112-6929

    Description

    Smiths Medical, CADD-Solis ambulatory infusion pumps, Models 2100, REF 21-2101-0200-51 and 2110, REF 21-2111-0100-51, Rx Only. Indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/ surgical wound site), epidural space, or subarachnoid space infusion.

    Reason

    Reports of non-delivery/ significant under-delivery of fluids when the CADD Medication Cassette Reservoir is not correctly latched to the pump. EXPANDED: On 7/14/11, Smith Medical expanded this recall to include all consignees with affected pumps.

    Action

    Smiths Medical sent a customer's bulletin notice dated April 11, 2011, only to the customers who reported this issue. Smiths Medical will work directly with the five Consignees who have reported complaints for this issue. The customer was instructed to read the attached Customer Information Bulletin. If you have additional questions on how to correctly latch a cassette to the pump, than please visit the following website: https://www.smiths-medical-education.com. Smiths Medical will also provide replacement pumps, as requested. This also will be considered an extension of Smiths Medical's investigation into this issue and to further validate the effectivity of the corrective and preventative actions in actual use. For further questions please call (651) 628-7280. EXPANDED: Consignees were sent a Smith Medical " Urgent Safety Alert" letter dated June, 30, 2011. The letter was addressed to Risk/ Safety Managers, Clinicians/ Biomedical Engineering, Nursing, Pharmacy, Pain Management and Anesthesia Professionals, Medical Equipment Rental Companies, Distributors and other users of these devices. The letter described the problem and the product. It provided "Advice on Action to be Taken by the User". This included to read the attached Customer information Bulletin and to complete and return the attached Confirmation Form.

    Distribution

    Worldwide Distribution -- (USA) nationwide including the states of AR, CA, MO, NY and WI., and the countries of BELGIUM, CANADA, SWITZERLAND, GERMANY, DENMARK, FRANCE, UNITED KINGDOM, IRELAND, ITALY, LUXEMBOURG, MALAYSIA, NETHERLANDS, NEW ZEALAND, PORTUGAL, QATAR, SAUDI ARABIA, SINGAPORE. *** EXPANDED*** AL, AK, AZ, CO, DC, FL, GA, ID, IL, IN, KY, LA, MD,MA, JI, MN, MT, NE, NH, NJ, NM, NC, OH, OK, OR, PA, RI, TN, TX, UT, VT, VA, WA, WY. UNITED ARAB EMIRATES, AUSTRIA, AUSTRALIA.

    Quantity

    4536 (3792 USA, 744 OUS)