Events

Device Recall AutoCAT 2 Series Intra 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Arrow International 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
    45871
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0550-2008
  • 사례 시작날짜
    2007-11-12
  • 사례 출판 날짜
    2008-01-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-01-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66372
  • 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
    Intra-Aortic Balloon and Control System - Product Code DSP
  • 원인
    Leak may occur in the helium drive system for the iabp.
  • 조치
    Arrow International notified customers by letter dated November, 2007 titled: Urgent Medical Device Field Correction. Customers are instructed to follow the Recommended Action included in the letter while awaiting replacement of the defective component to be performed by service representative.

Device

Device Recall AutoCAT 2 Series Intra
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 070405V, 070411V, 070412V, 070413V, 070415V, 070416V, 070420V, 070421V, 070422V, 070423W, 070424V, 070426V, 070501V, 070502W, 070503W, 070510V, 070512W, 070513V, 070514W, 070518V, 070520W, 070522W, 070523W, 070524V, 070525W, 070526V, 070527V, 070528W, 070529V, 070530W, 070531W, 070532W, 070533W, 070534W, 070535W, 070536W, 070537V, 070538V, 070539V, 070540W, 070601W, 070602W, 070603V, 070604V, 070605W, 070606W, 070607W, 70608W, 070609W, 070610W, 070611W, 070612W, 070613W, 070614W, 070615W, 070616W, 070617W, 070618W, 070619W, 70620W, 070621W, 070622W, 070623W, 070624W, 070625W, 070626W, 070627W, 70628W, 070629W, 070630W, 070631W, 070632W, 070633W, 070634W, 070635W, 070636W, 070637W, 070638W, 070639W, 070640W, 070641W, 070642W, 070643W, 070644V, 070645W, 070646V, 070647V, 070648V, 070649W, 070650V, 31122V, 41146W, 51007W, 60930W, 60939W, 70111W, 70112W, 70113V, 70114W, 70115W, 70116V, 70117W, 70118W, 70119W, 70120W, 70121W, 70122W, 70123W, 70124V, 70125W, 70126V, 70127W, 70128V, 70129W, 70130W, 70131W, 70132W, 70133W, 70134W, 70135W, 70136W, 70137W, 70138W, 70139W, 70140W, 70141V, 70142W, 70143W, 70144W, 70145W, 70146W, 70147W, 70148W, 70149W, 70150W, 70201W,70202W, 70203W, 70204W, 70205W, 70206W, 70207W, 70208W, 70209W, 70210W, 70211W, 70212W, 70213W, 70214W, 70215W, 70216W, 70217W, 70218W, 70219W, 70220W, 70221V, 70222V, 70223W, 70224V, 70225W, 70226V, 70227W, 70228W, 70229V, 70230V, 70231W, 70232V, 70233W, 70234V, 70235V, 70236V, 70237W, 70238W, 70239W, 70240W, 70301W, 70302W, 70303W, 70304W, 70305W, 70306W, 70307W, 70308W, 70309W, 70310W, 70311W, 70312V, 70313W, 70314W, 70315V, 70316W, 70317W, 70318W, 70319V, 70320W, 70401W, 70402W, 70403W, 70404W, 70406W, 70407W, 70408W, 70409W, 70410W, 70414W, 70417W, 70418W, 70419W, 70425W, 70427W, 70428W, 70429W, 70430W, 70504W, 70505W, 70506V, 70507W, 70508W, 70509W, 70511W, 70515W, 70516W, 70517W, 70519W, and 70521V
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide- USA, including the states of CA, CO, FL, IN, KS, MA, MO, NV, NY, PA, SC, TN, TX, and WA and countries of Canada, Africa, Argentina, Austria, Bangladesh, Belarus, Belgium, Brazil, Canada, Columbia, Czech Rep, UK, Finland, France, Germany, Hungary, India, Indonesia, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Panama, Philippines, Portugal, Russia, Saudi Arabia, Italy, Spain, Sweden, Taiwan, and Turkey.
  • 제품 설명
    AutoCAT 2 Series Intra-Aortic Balloon Pumps || Catalog No: IAP-0400, IAP-0435, IAP-0500, and IAP-0535, Arrow International, Everett, MA 02149
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc
  • 제조사 주소
    Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
  • 제조사 모회사 (2017)
    Teleflex Incorporated
  • Source
    USFDA