BEUDAMED
    FDA Enforcement Class II Terminated

    Smiths Medical, Deltec: REF 21-8011-24 Port-A-Cath Dual-Lumen. Titanium Venous Access System. REF 21-8052-24 & REF 21-8053-24 , Port-A-Cath II Dual-Lumen, Polysulfone /Titanium Venous Access System. Sterile EO, Rx Only. PORT-A-CATH¿ and PORT-A-CATH¿ II implantable venous and arterial access systems are designed to permit repeated access to the vascular system for the parenteral delivery of medications, fluids, and nutritional solutions and for the sampling of venous blood. Introducer sets are indicated for the introduction of catheters into the subclavian vein.

    Recall: Z-2269-2013 · Reported October 2, 2013

    Enforcement

    Recall Number
    Z-2269-2013
    Event ID
    66234
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smiths Medical ASD, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 2, 2013
    Initiation Date
    September 10, 2013
    Classification Date
    September 23, 2013
    Termination Date
    October 21, 2014
    Address
    1265 Grey Fox Rd, N/A, Saint Paul, MN, 55112-6929, United States

    Description

    Smiths Medical, Deltec: REF 21-8011-24 Port-A-Cath Dual-Lumen. Titanium Venous Access System. REF 21-8052-24 & REF 21-8053-24 , Port-A-Cath II Dual-Lumen, Polysulfone /Titanium Venous Access System. Sterile EO, Rx Only. PORT-A-CATH¿ and PORT-A-CATH¿ II implantable venous and arterial access systems are designed to permit repeated access to the vascular system for the parenteral delivery of medications, fluids, and nutritional solutions and for the sampling of venous blood. Introducer sets are indicated for the introduction of catheters into the subclavian vein.

    Reason

    Smiths Medical is conducting a voluntary recall of PORT-A-CATH¿ and PORT-A-CATH¿ II Implantable Venous and Arterial Access Systems and Introducer Sets. Smiths Medical has become aware of a small number of customer reports regarding the introducer sheath and the introducer opening being too small for the width of the catheter with the use of these Sets. Smiths Medical has received no reports

    Code Info

    21-8011-24: 1971567 1979805 1984078 1997124 2006124 2038001 2090898 2151160 2196530 2216256 2249695 21-8052-24: 1971572 2012472 2022904 2067947 2080704 2146472 2168988 2196532 2207404 2237458 2249696 2269178 2282158 21-8053-24: 2168989 2249697

    Distribution

    Worldwide Distribution - USA including AZ, AR, CA, GA, IL, IN, KY, MD, MA, MI, NV, NJ, NY, NC, OH, OR, PA, RI, SC, TN, TX, VA, WA, WV, WY. Internationally to DENMARK, BELGIUM CANADA.

    Quantity

    372