Devices

Device Recall Zilver

  • 모델명 / 제조번호(시리얼번호)
    Lot 1557057.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    California, Pennsylvania, Utah and Canada.
  • 제품 설명
    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.
  • 1 Event

제조사

Cook, Inc.
  • 제조사 주소
    Cook, Inc., 750 Daniels Way, Bloomington IN 47404-9120
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 4 건

데이터에 대해 더 자세히 알아보기 여기

Device Recall Zilver 518RX Vascular Stent
  • 모델명 / 제조번호(시리얼번호)
    Catalog Prefix ZIVX5. All Lots
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Worldwide
  • 제품 설명
    Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System
  • Manufacturer
    Cook Medical Incorporated
Device Recall Zilver
  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    The product was distributed to hospitals located nationwide and worldwide.
  • 제품 설명
    Zilver Expandable Metal Biliary Stent
  • Manufacturer
    Wilson-Cook Medical Inc
Device Recall Zilver Expandable Metal Biliary Stent System.
  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    The device was distributed nationwide, Ireland and Jordan.
  • 제품 설명
    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 518 Vascular Self Expanding Stent
  • 모델명 / 제조번호(시리얼번호)
    Part order number: ZIV5-18-125-8-80; Lot Number: CF694429; Expiration Date: 09-2014
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution: USA (nationwide) and country of: Japan.
  • 제품 설명
    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.