Events

Device Recall Target Detachable Coils 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Neurovascular 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
    74425
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2164-2016
  • 사례 시작날짜
    2016-06-06
  • 사례 출판 날짜
    2016-07-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-03-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147545
  • 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
    Device, neurovascular embolization - Product Code HCG
  • 원인
    Stryker neurovascular has become aware that some units of target nano product do not have the intended stretch resistance. the sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.
  • 조치
    Stryker Neurovascular sent an Urgent Medical Device Voluntary Recall letter dated June 3, 2016, to all affected customers via FED Ex. Letter includes recall letter, list of impacted lot numbers, customer acknowledgement form and frequently asked questions. Customers were instructed to immediately check their inventory. segregate the effected inventory in a secure location for return to Stryker, circulate the Field Safety Notice internally to all interested/affected parties. Inform Stryker if any of the subject devices have been distributed to other organizations. Customers were also instructed to complete the attached customer response form and return the completed form to their nominated Stryker Representative.

Device

Device Recall Target Detachable Coils
  • 모델명 / 제조번호(시리얼번호)
    MODEL Number: M0035421540  Lot Number/Expiration Date: 18808912 31-Jan-19 18741434 31-Dec-18 18714072 30-Nov-18 18677229 30-Nov-18 18625483 31-Oct-18 18625541 31-Oct-18 18642784 31-Oct-18 18633921 31-Oct-18 18598299 30-Sep-18 18590470 30-Sep-18 18542363 31-Aug-18 18420011 31-May-18 18419897 31-May-18 18833256 28-Feb-19 18808618 31-Jan-19 18787244 31-Jan-19 18677171 30-Nov-18 18524564 31-Jul-18 18524622 31-Jul-18 18832645 31-Jan-19 18768683 31-Dec-18 18756119 31-Dec-18 18725503 30-Nov-18 18666721 31-Oct-18 18642842 31-Oct-18 18642668 31-Oct-18 18598183 30-Sep-18 18590528 30-Sep-18 18578953 30-Sep-18 18406806 31-May-18 18809794 31-Jan-19 18787859 31-Jan-19 18755053 31-Dec-18 18741144 31-Dec-18 18701144 30-Nov-18 18590586 30-Sep-18 18579069 30-Sep-18 18549270 31-Aug-18 18420182 31-May-18 18420239 31-May-18 18809206 31-Jan-19 18817972 28-Feb-19 18701318 30-Nov-18 18677113 30-Nov-18 18488340 31-Jul-18 18598125 30-Sep-18 18542305 31-Aug-18 18787449 31-Jan-19 18714246 30-Nov-18 18625599 31-Oct-18 18634037 31-Oct-18 18598241 30-Sep-18 18559192 31-Aug-18 18832034 31-Jan-19 18817309 28-Feb-19 18787654 31-Jan-19 18768041 31-Dec-18 18701260 30-Nov-18 18809500 31-Jan-19 18701202 30-Nov-18 18677287 30-Nov-18 18642726 31-Oct-18 18590412 30-Sep-18 18559250 31-Aug-18 19080127 31-May-19 19010580 30-Apr-19 18931017 31-Mar-19 18885811 28-Feb-19 18846227 28-Feb-19 19026877 30-Apr-19 19025829 30-Apr-19 19043083 31-May-19 18974705 30-Apr-19 18957691 31-Mar-19 18911592 31-Mar-19 18845848 28-Feb-19 19049933 31-May-19 18998580 30-Apr-19 18853712 28-Feb-19 18887225 28-Feb-19 19080305 31-May-19 19026353 30-Apr-19 18998638 30-Apr-19 18975142 30-Apr-19 18956531 31-Mar-19 19079949 31-May-19 18964774 31-Mar-19 19042039 30-Apr-19 19010180 30-Apr-19 18963382 31-Mar-19 18912801 31-Mar-19 18911995 31-Mar-19 18846606 28-Feb-19 18963846 31-Mar-19 18930672 31-Mar-19 18899164 28-Feb-19 18912398 31-Mar-19 18974268 30-Apr-19 18987031 30-Apr-19 19050975 31-May-19 19048891 31-May-19 19042561 31-May-19 19041517 30-Apr-19 18964310 31-Mar-19 18975579 30-Apr-19 18957111 31-Mar-19 18940339 31-Mar-19 18938917 31-Mar-19 18929982 31-Mar-19 18845469 28-Feb-19.
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.
  • 제품 설명
    Target Detachable Coils: || TARGET 360 NANO 1.5 MM X 4 CM || MODEL Number:M0035421540 || Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
  • Manufacturer
    Stryker Neurovascular

Manufacturer

Stryker Neurovascular
  • 제조사 주소
    Stryker Neurovascular, 47900 Bayside Pkwy, Fremont CA 94538-6515
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA