Events

Cook brand Zenith AAA Bifurcated main body graft with the H&L-B; One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 26 mm - iliac leg diameters 11 mm - main body lengths contralateral limb 88mm ipsilateral limb 133 mm - delivery system 18 FR; Catalog no. TFB-26-88. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cook, Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    29300
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1175-04
  • 사례 시작날짜
    2004-06-10
  • 사례 출판 날짜
    2004-07-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2004-11-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33865
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    System, Endovascular Graft, Aortic Aneurysm Treatment - Product Code MIH
  • 원인
    Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.
  • 조치
    The firm issued recall letters to customers on 6/10/04. The recall was extended and URGENT EXTENSION OF PRODUCT RECALL notices were sent out on June 23, 2004.

Device

Cook brand Zenith AAA Bifurcated main body graft with the H&L-B; One-Shot Introducer System, prel...
  • 모델명 / 제조번호(시리얼번호)
    Lots 1356570, 1352816, F1532289, F1530605, F1530606, F1530607, F1530608, F1537420, F1537421, F1535722, F1535723, F1532174, F1532175, F1537387, F1541243, F1543309, F1538047, F1543310, F1538048, F1538049, F1537422, F1537423, F1539271, F1539272, F1543308, F1548065, F1548066, F1548067, F1546891, F1549744, F1552056, F1548096, F1548097, F1548098, F1552057, F1552059, F1556703, F1556705, F1556706, F1554799, F1554800, F1554801, F1552058, F1556704, F1560042, F1560043, F1560044, F1560046, F1560045, F1565064, F1565094, F1565095, F1565096, F1565062, F1567253, F1569227, F1565093, F1567905, F1567906, F1567907, F1565063, F1570153, F1567252, F1567254, F1572847, F1572849, F1572850, F1572851, F1571623, F1572845, F1572846, F1572848, F1575180, F1575182, F1575118, 1361941, 1356566, 1356572, 1356569, 1343123, 1349758, 1352814, 1361944, 1352811 and 1365178.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide, Canada, Denmark and Japan.
  • 제품 설명
    Cook brand Zenith AAA Bifurcated main body graft with the H&L-B; One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 26 mm - iliac leg diameters 11 mm - main body lengths contralateral limb 88mm ipsilateral limb 133 mm - delivery system 18 FR; Catalog no. TFB-26-88.
  • Manufacturer
    Cook, Inc.

Manufacturer

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