Device Recall Digitex 20 Polydioxanone (PDO) suture

  • Modelo / Serial
    Lots 3390331, 3390339, 3390490.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Distribution to: KY, MI, OH, PR, TX, and VA.
  • Descripción del producto
    Digitex Absorbable Polydiaxanone Suture, Size 2-0. || Catalog Number / Code of product: 52031, 5203101400. || The Digitex Delivery Device is a sterile, disposable device intended to deliver a suture to the operative site. The device assists in suturing by passing a needle through the tissue to capture the suture, and suture ligation and know-typing by holding the suture.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Coloplast Manufacturing US, LLC, 1601 W River Rd, Minneapolis MN 55411-3431
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA