Device Recall Zilver

  • Modelo / Serial
    Lot 1557057.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    California, Pennsylvania, Utah and Canada.
  • Descripción del producto
    Cook Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 8.0 mm, stent length 40 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wire guide size .035 inch dia., sterile; Catalog # ZIB6-80-8.0-40.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Cook, Inc., 750 Daniels Way, Bloomington IN 47404-9120
  • Source
    USFDA

4 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Catalog Prefix ZIVX5. All Lots
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Worldwide
  • Descripción del producto
    Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System
  • Manufacturer
  • Modelo / Serial
    Reorder #ZILBS-6-6 ZILBS-10-8, ZILBS10-6, Amended 8/8/2003 to include: ZILBS-10-4, ZILBS-8-4, ZILBS-8-6, ZILBS-8-8, ZILBS6-4, ZILBS-6-8
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    The product was distributed to hospitals located nationwide and worldwide.
  • Descripción del producto
    Zilver Expandable Metal Biliary Stent
  • Manufacturer
  • Modelo / Serial
    Catalog number: ZILBS-10-4, ZILBS-6-4, ZILBS-8-4, ZILBS-10-6, ZILBS-6-6, ZILBS-8-6, ZILBS-10-8, ZILBS-6-8, ZILBS-8-8, Lot number: 1616783, 1616787, 1622794, 1622798, 1622802, 166958, 1622966, 162970, 162993, 1623007, 1623016, 1626424, 1631805, 1616784, 1616788, 1622795, 1622799, 1622803, 1622959, 1622803, 1622959, 1622963, 1622967, 1622982, 1622994, 1623008, 1623017, 1631388, 1633707, 1616785, 1616789, 1622796, 1622800, 1622804, 1622960, 1622964, 1622968, 1622985, 1623001, 1623009, 1623018, 1631803, 1634239, 1616786, 1616790, 1622797, 1622801, 1622956, 1622961, 1622965, 1622969, 1622986, 1623002, 1623015, 1626423, 1631804, 1635626.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    The device was distributed nationwide, Ireland and Jordan.
  • Descripción del producto
    ZILBS-8-6, ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM, Stent Diameter: 8 MM. Stent Length: 6 CM., Accepts .035'' Wire Guide, Introduction system: 7 FR., Minimum Scope Channel: 2.8 MM., Disposable-Single Use Only, Rx Only, Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.
  • Manufacturer
  • Modelo / Serial
    Part order number: ZIV5-18-125-8-80; Lot Number: CF694429; Expiration Date: 09-2014
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: USA (nationwide) and country of: Japan.
  • Descripción del producto
    Zilver 518 Vascular Self Expanding Stent || The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic disease of iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm. Patients should be suitable candidates for PTA and / or stent treatment.
  • Manufacturer