Devices

Device Recall Zilver

  • Modèle / numéro de série
    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
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    The product was distributed to hospitals located nationwide and worldwide.
  • Description du dispositif
    Zilver Expandable Metal Biliary Stent
  • Manufacturer
    Wilson-Cook Medical Inc
  • 1 Event

Fabricant

Wilson-Cook Medical Inc
  • Adresse du fabricant
    Wilson-Cook Medical Inc, 4900 Bethania Station Rd, & 5951 Grassy Creek Blvd., Winston-Salem NC 27105
  • Source
    USFDA

4 dispositifs médicaux avec un nom similaire

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Device Recall Zilver 518RX Vascular Stent
  • Modèle / numéro de série
    Catalog Prefix ZIVX5. All Lots
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Worldwide
  • Description du dispositif
    Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System
  • Manufacturer
    Cook Medical Incorporated
Device Recall Zilver Expandable Metal Biliary Stent System.
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    The device was distributed nationwide, Ireland and Jordan.
  • Description du dispositif
    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
    Wilson-Cook Medical Inc
Device Recall Zilver
  • Modèle / numéro de série
    Lot 1557057.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    California, Pennsylvania, Utah and Canada.
  • Description du dispositif
    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
    Cook, Inc.
Device Recall Zilver 518 Vascular Self Expanding Stent
  • Modèle / numéro de série
    Part order number: ZIV5-18-125-8-80; Lot Number: CF694429; Expiration Date: 09-2014
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution: USA (nationwide) and country of: Japan.
  • Description du dispositif
    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
    Cook Ireland Ltd.