BEUDAMED
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    BARD BrachySource Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-coated, gold-cored aluminum wire (reference Figure 1 below). The I125 has a half-life of 59.6 days and decays by electron capture with the emission of characteristic photons and Auger electrons. The principal photon emissions are 27.4 and 31 keV x-rays and 35.5 keV gamma. The titanium wall of the BrachySource Seed Implants absorbs the electrons.

    FDA Recall
    Terminated ·Bard Brachytherapy, Inc.·Product code KXK·April 10, 2018

    BARD¿ BrachySource¿ Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-coated, gold-cored aluminum wire (reference Figure 1 below). The I125 has a half-life of 59.6 days and decays by electron capture with the emission of characteristic photons and Auger electrons. The principal photon emissions are 27.4 and 31 keV x-rays and 35.5 keV gamma. The titanium wall of the BrachySource¿ Seed Implants absorbs the electrons.

    FDA Enforcement
    Class II ·Terminated·Bard Brachytherapy, Inc.·May 16, 2018

    SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces. The SenTec V-Sign Membrane Changer Insert is indicated for use with the V-Sign Membrane Changer only. The V-sign Sensor is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate are required for adult and pediatric patients.

    FDA Enforcement
    Class II ·Terminated·Sentec AG·November 28, 2012

    SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces. The SenTec V-Sign Membrane Changer Insert is indicated for use with the V-Sign Membrane Changer only. The V-sign Sensor is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate are required for adult and pediatric patients.

    FDA Recall
    Terminated ·Sentec AG Ringstrasse 39 Therwil, Baselland Switzerland·Product code LKD·November 5, 2012

    Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999L74, Exu-Dry Sheet 36"x72" Permeable with Straps Quilted, Smith & Nephew, Inc.,Largo, Florida.

    FDA Recall
    Terminated ·Smith And Nephew, Inc. Wound Management Division·Product code MCY·November 21, 2007

    Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999018, Exu-Dry Dressing, 15" x 18", Smith & Nephew, Inc.,Largo, Florida.

    FDA Recall
    Terminated ·Smith And Nephew, Inc. Wound Management Division·Product code MCY·November 21, 2007

    Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999LV1, Exu-Dry Large Burn Vest, Smith & Nephew, Inc.,Largo, Florida

    FDA Recall
    Terminated ·Smith And Nephew, Inc. Wound Management Division·Product code MCY·November 21, 2007

    Material DT7890, PORT ACCESS TRAY, CENTURION HEALTHCARE PRODUCTS PORT ACCESS TRAY, REORDER DT7890, STERILE, TRI-STATE HOSPITAL SUPPLY Manufacturers of CENTURION Healthcare Products Howell, MI 48843 USA (800) 248-4058 www.tshsc.com FACILITATES PORT INSERTION

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code MCY·March 31, 2011

    Material DT12050, PORT ACCESS TRAY, CENTURION Port Access Tray, Reorder DT 12050, STERILE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895 USA 800.248.4058 www.centurionmp.com FACILITATES LINE INSERTION DT12050 PORT ACCESS TRAY

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code MCY·March 31, 2011

    Material HT2480, V.A.D. TRAY, CENTURION V.A.D. TRAY, REORDER HT2480, STERILE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.4058 www.centurionmp.com FACILITATES LINE INSERTION

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code MCY·March 31, 2011

    Material HT2430A, V.A.D.TRAY, CENTURION V.A.D. TRAY, REORDER HT2430A, STERILE, LATEX FREE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.4058 www.centurionmp.com FACILITATES LINE INSERTION

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code MCY·March 31, 2011

    Material DT12400, PORT ACCESS TRAY, CENTURION PORT ACCESS TRAY, REORDER DT12400, STERILE, LATEX FREE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.4058 www.centurionmp.com FACILITATES LINE INSERTION DT12050 PORT ACCESS TRAY

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code MCY·March 31, 2011

    WOUND CLOSURE TRAY I CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code MCY·July 10, 2015

    Dressing Change Tray for Hickman & Dialysis Catheters, DT12110, Sterile, Centurion Medical Products Corp., Williamston, MI. These kits are used for dressing changes.

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code MCY·January 14, 2011

    IN-PATIENT Port Access Dressing Tray, DT14880, Sterile, Centurion Medical Products Corp., Williamston, MI. These kits are used for dressing changes.

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code MCY·January 14, 2011

    Material DT9155, PORT ACCESS TRAY W/SORBAVIEW&CHLORAPREP, CENTURION PORT ACCESS TRAY WITH SORBAVIEW AND CHLORAPREP, REORDER DT9155, STERILE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.4058 www.centurionmp.com FACILITATES PORT INSERTION

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code MCY·March 31, 2011

    Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999M28, Exu-Dry Dressing, 15" x 28", Smith & Nephew, Inc.,Largo, Florida.

    FDA Recall
    Terminated ·Smith And Nephew, Inc. Wound Management Division·Product code MCY·November 21, 2007

    Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999L72,Exu-Dry Sheet 36"x72" Non-Permeable, Smith & Nephew, Inc.,Largo, Florida

    FDA Recall
    Terminated ·Smith And Nephew, Inc. Wound Management Division·Product code MCY·November 21, 2007

    Material DT7150, PORT ACCESS TRAY, CENTURION PORT ACCESS TRAY, REORDER DT7150, STERILE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.4058 www.centurionmp.com FACILITATES PORT INSERTION

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code MCY·March 31, 2011

    Material DT12910, PORT ACCESS TRAY W/ SECUREVIEW, CENTURION PORT ACCESS TRAY W/ SECUREVIEW, REORDER DT12910, STERILE, LATEX FREE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.4058 www.centurionmp.com

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code MCY·March 31, 2011