Events

Device Recall Bard 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Enpath Medical, 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
    35827
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0118-2007
  • 사례 시작날짜
    2006-06-27
  • 사례 출판 날짜
    2006-11-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-04-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46968
  • 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
    guide catheter delivery sheath - Product Code DQY
  • 원인
    Enpath has become aware that some of the enpath medical 8f & 9f steerable sheath devices may have a non-conforming flushport bond that causes a leak where air may enter the flush port chamber.
  • 조치
    Enpath''s three Distributors were notified via letter or telephone on June 27th, 29th and July 6th with a description of the problem and further distribution or use of any remaining product should cease immediately. Instructed to notify their customers about the product and forward to Enpath for evaluation.

Device

Device Recall Bard
  • 모델명 / 제조번호(시리얼번호)
    Model # 8F: Enpath Part Number 10775-003, BARD Part Number XD10775003 (Distributed in US and Internationally). 8F Lots #s W34968 (80 units), W35440 (35 units), W35522 (40 units), W35705 (17 units, sent as SAMPLES, labeled NOT FOR HUMAN USE), W35719 (320 units), W35952 (79 units), W37292 (300 units), W37567 (116 units), W38340 (298 units), W38341 (87 units), W38342 (87 units), W38974 (99 units), W38975 (100 units), W39174 (100 units), W40410 (100 units), W40479 (87 units), W40480 (85 units), W40481 (100 units), W40483 (87 units).  Model # 9F: Enpath Part Number 10775-004 (9F), BARD Part Number XD10775004, (Distributed Internationally (EU) only), 9F lot #s; W36392 (3 units), W36623 (5 units), W36884 (2 units), W36974 (8 units).
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    CA, MA
  • 제품 설명
    Channel Steerable Sheath in 8F Enpath part # 10775-003, BARD Part Number XD10775003 (US Distribution Only) and 9F Enpath part # 10775-004 (foreign distribution), BARD Part Number XD10775004; Labeled as Distributed by Bard Electrophysiology Division.
  • Manufacturer
    Enpath Medical, Inc.

Manufacturer

Enpath Medical, Inc.
  • 제조사 주소
    Enpath Medical, Inc., 15301 Highway 55, Plymouth MN 55447-1418
  • Source
    USFDA