Events

Product is a Pruitt Aortic Occlusion Catheter contained in a molded tray. The product is labeled in part: ''***LeMaitre VASCULAR***Distributed By:LeMaitre Vascular, Inc.***Manufactured By: LeMaitre Vascular, Inc. 3101 37th Avenue North St. Petersburg, FL 33713***Pruitt Aortic Occlusion Catheter***REF 2101-12***STERILE***''. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 LeMaitre Vascular, 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
    32971
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0219-06
  • 사례 시작날짜
    2005-05-17
  • 사례 출판 날짜
    2005-11-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-07-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41161
  • 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
    Occluder, Catheter Tip - Product Code DQT
  • 원인
    Lemaitre vascular is recalling certain lots of its pruitt aortic occlusion catheters due to a packaging defect which could compromise product sterility.
  • 조치
    The distributors in Europe and Japan have been notified to contact their customers to return the products. All customers have been notified by letter.

Device

Product is a Pruitt Aortic Occlusion Catheter contained in a molded tray. The product is labeled...
  • 모델명 / 제조번호(시리얼번호)
    Lot No: 1010505-07, 1010505-08, 1030404-09, 104104-05, 1041404-06, 1042204-12, 1042704-01, 1042704-03, 1052204-01, 1061404-04, 1061404-05, 1070204-03, 1080204-08, 1082304-06, l100604-01, l100704-01, l120104-02, l121604-04.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    There are two lots in distribution (175 pieces) that may contain the small hole in the tray. These two lots were distributed in Japan and Europe. There are 16 lots in distribution (1,744 pieces) that utilize the trays with the thin spots that can potentially crack. These 16 lots were distributed in the United States, Canada, Japan and the European Union.
  • 제품 설명
    Product is a Pruitt Aortic Occlusion Catheter contained in a molded tray. The product is labeled in part: ''***LeMaitre VASCULAR***Distributed By:LeMaitre Vascular, Inc.***Manufactured By: LeMaitre Vascular, Inc. 3101 37th Avenue North St. Petersburg, FL 33713***Pruitt Aortic Occlusion Catheter***REF 2101-12***STERILE***''.
  • Manufacturer
    LeMaitre Vascular, Inc.

Manufacturer

LeMaitre Vascular, Inc.
  • 제조사 주소
    LeMaitre Vascular, Inc., 3101 37th Ave N, St Petersburg FL 33713-1509
  • Source
    USFDA