Events

Device Recall LeMaitre Vascular AnastoClip AC Closure System 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
    74563
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2285-2016
  • 사례 시작날짜
    2016-06-22
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147907
  • 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
    Clip, implantable - Product Code FZP
  • 원인
    Us marketing brochure for the anastoclip ac closure system states that the anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.
  • 조치
    The firm, LeMaitre Vascular, Inc., sent an "URGENT: Medical Device Correction" letter dated June 20, 2016 to its distributors and hospitals via Priority mail. The letter describes the product, problem and actions to be taken. The customers were informed of the intended use of the devices and the correct catalog numbers to order for the dura application. The customers were instructed to return unused devices for an exchange or refund; destroy any Anastoclip related marketing materials that you have received from Lemaitre between October 25- 2015 and June 15, 2016, and complete and return the reply form for reconciliation of this recall via fax at 781-221-2223, email: CSUS@LEMAITRE.COM or by mail. LeMaitre Vascular, Inc. will replace any affected device with a new device labeled for dura closure or issue a credit per request. Questions concerning this safety notice, please contact me at 781-221-2266 ext. 183.

Device

Device Recall LeMaitre Vascular AnastoClip AC Closure System
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: ANC1487¿ ANC1665¿ ANC1672¿ ANC1683¿ ANC2002¿ ANC2003¿ ANC2010¿ ANC2011¿
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Anasto AC Closure System and Anasto Universal Clip Remover- Anasto AC 8cm 25 Clips (1 Each} X-Large || REF # 4000-08 || The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.
  • Manufacturer
    LeMaitre Vascular, Inc.

Manufacturer

LeMaitre Vascular, Inc.
  • 제조사 주소
    LeMaitre Vascular, Inc., 63 2nd Ave, Burlington MA 01803-4413
  • 제조사 모회사 (2017)
    LeMaitre Vascular, Inc.
  • Source
    USFDA