Device Recall InterDry Ag

  • Modelo / Serial
    Lot 1789435
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, including states of AL, AZ, CA, CT, FL, GA, IL, IN, IA, KY. LA, MI, MA,MO, MN, MS, MD, NE, NV, NH, NJ, NM, NY, NC, OH, OK OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI and country of CANADA.
  • Descripción del producto
    Coloplast, InterDry Ag 10" x 144" Roll P/N 6791001400, Manufactured for Coloplast A/S DK-3050 Humlebaek, Denmark, Distributed by Coloplast Corp Minneapolis MN 55411. || InterDry" is a non-sterile, knitted, polyurethane-coated polyester textile impregnated with an antimicrobial silver complex used for the management of skin fold complications. || The textile provides moisture transportation to keep skin dry while the antimicrobial in the textile reduces odor. The textile's low friction surface acts as a lubrication aid, thereby reducing skin-to-skin friction. InterDry" provides a protective environment for the skin and an effective protection against microbial contamination in the fabric. The product reduces colonization of the following gram-negative and gram-positive bacterial as well as yeast. Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa and Candida albicans. InterDry" Ag Textile contains 0.01% silver and is a single patient use product that is custom cut from a multi-use package.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Coloplast Corp Skin Care Div, 1940 Commerce Dr, North Mankato MN 56003-1700
  • Source
    USFDA