Events

9F Pruitt F3 Outlying Carotid Shunt with Tport 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
    60007
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0070-2012
  • 사례 시작날짜
    2011-10-04
  • 사례 출판 날짜
    2011-10-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-03-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104225
  • 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
    Catheter, intravascular occluding, temporary - Product Code MJN
  • 원인
    Extended expiration on the outer box label 2016-05, the correct expiration date is on the tray label: 2014-05.
  • 조치
    The firm, LeMaitre Vascular, Inc., sent an "URGENT: 9F PRUITT F3 Carotid Shunt Device Field Safety Notice" dated October 4, 2011 to its customers. The notice describes the product, problem and action to be taken. The customers were instructed to identify their inventory; return the affected products for exchange with a properly labeled device; contact Le Matire customer service for replacement at 800-628-9470, and complete and return the RECALL NOTICE RECONCILIATION FORM via fax to 781-425-5049, even if no product is on hand. If you have any questions concerning this safety notice, please contact the Quality Assurance Engineer at 781-221-2266 ext. 183.

Device

9F Pruitt F3 Outlying Carotid Shunt with Tport
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: PFT2209
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: USA including states of: CA, FL, IA, IL, MA, MI, NE, NJ, NY, OH, SC, TX, and WI.
  • 제품 설명
    LeMaitre 9F Pruitt F3 Outlying Carotid Shunt with T-port || The Pruitt F3 Carotid Shunt (the Shunt) is a multi-lumen device with balloons at both the distal (internal carotid) and proximal (common carotid) ends of the shunt. The balloons, when inflated independently, act as a stabilization mechanism to maintain the position of the Shunt when it is placed within the common and internal carotid arteries. An external safety balloon located on the inflation arm leading to the distal (internal carotid) balloon acts as a mechanism to relieve pressure on the internal carotid balloon in the event it inflates above optimal size and pressure. The external safety balloon feature reduces the possibility of balloon over-inflation and resultant vessel damage. The Pruitt F3 Carotid Shunt has features to aid the user during shunt insertion and balloon inflation. The inflation path of the proximal (common carotid) balloon is color coded. Sterile saline is injected from the blue stopcock, through the blue lumen and into the blue common carotid balloon. The sleeve of the external safety balloon is yellow, to increase its visibility. Depth markings on the shunt body are for reference during insertion
  • Manufacturer
    Lemaitre Vascular, Inc.

Manufacturer

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