Events

LeMaitre Vascular AnastoClip GC Vessel Closure SystemMedium Size Models: 400702 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
    56908
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0164-2011
  • 사례 시작날짜
    2010-09-22
  • 사례 출판 날짜
    2010-10-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-09-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94900
  • 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
    Applier, hemostatic clip - Product Code HBT
  • 원인
    Mislabeled size on external packaging: the contents section listed on the tyvek lid labels of the medium and large sizes incorrectly identified the size of the clip as xl, while the device inside was either a medium or large size.
  • 조치
    LeMaitre Vascular issued an Urgent AnastoClip GC Device Field Safety Notice letter dated Sepember 28, 2010 identifying the affected devices and actions to be taken by customers. The letter contains a form that is requested to be returned to LeMaitre Vascular as record of notification and reconciliation. The letter provides an option for the notified hospital to return the affected product for replacement if unused or if they simply wish to have it corrected. Customers can contact LeMaitre Customer Service for replacement at 800 628-9470.

Device

LeMaitre Vascular AnastoClip GC Vessel Closure SystemMedium Size Models: 400702
  • 모델명 / 제조번호(시리얼번호)
    Lot Number Expiration Date  AGC1015 2012-10 AGC1016 2012-10 AGC1017 2012-10 AGC1018 2012-11 AGC1019 2012-11 AGC1022 2012-11 AGC1023 2012-11 AGC1024 2012-12 AGC1025 2013-01 AGC1027 2013-01 AGC1028 2013-01
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution: to the states of CA, FL, GA, IL, IN, LA, MD, MS, NJ, OK, OR, and TX.
  • 제품 설명
    LeMaitre Vascular AnastoClip GC Vessel Closure System-Medium Size || Models: || 4007-02 Medium size 3 Pack || 4008-02 Medium size 10 Pack || 4007-06 Medium size 1 Pack || Manufactured by LeMatire Vascular Inc, Burlington, MA 01803
  • Manufacturer
    Lemaitre Vascular, Inc.

Manufacturer

Lemaitre Vascular, Inc.
  • 제조사 주소
    Lemaitre Vascular, Inc., 63 2nd Ave, Burlington MA 01803-4413
  • Source
    USFDA