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-2176-2016
  • 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=147577
  • 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: M0035443060:  Lot Number/Expiration Date: 18826753 31-Jan-19 18826606 31-Jan-19 18794421 31-Jan-19 18777349 31-Dec-18 18750808 31-Dec-18 18754448 31-Dec-18 18760112 31-Dec-18 18491003 31-Jul-18 18443198 30-Jun-18 18827047 31-Jan-19 18816704 31-Jan-19 18776301 31-Dec-18 18750603 31-Dec-18 18491065 31-Jul-18 18442058 30-Jun-18 18808498 31-Jan-19 18783540 31-Jan-19 18764659 31-Dec-18 18750193 31-Dec-18 18708724 30-Nov-18 18491096 31-Jul-18 18443258 30-Jun-18 18443228 30-Jun-18 18393950 31-May-18 18817367 31-Jan-19 18782584 31-Jan-19 18755514 31-Dec-18 18703469 30-Nov-18 18443018 30-Jun-18 18442958 30-Jun-18 18442538 30-Jun-18 18441728 30-Jun-18 18436622 30-Jun-18 18827341 31-Jan-19 18809086 31-Jan-19 18809674 31-Jan-19 18765615 31-Dec-18 18750398 31-Dec-18 18471007 31-Jul-18 18490724 31-Jul-18 18818030 31-Jan-19 18760113 31-Dec-18 18708786 30-Nov-18 18490972 31-Jul-18 18442508 30-Jun-18 18442268 30-Jun-18 18827194 31-Jan-19 18703264 30-Nov-18 18490910 31-Jul-18 18442568 30-Jun-18 18827488 31-Jan-19 18826900 31-Jan-19 18808792 31-Jan-19 18443048 30-Jun-18 19013252 30-Apr-19 19000510 30-Apr-19 18951824 31-Mar-19 18853836 28-Feb-19 19028176 30-Apr-19 18990655 30-Apr-19 19041022 31-May-19 19040295 31-May-19 19000572 30-Apr-19 18960708 31-Mar-19 18902391 28-Feb-19 19013163 30-Apr-19 19066272 31-May-19 19063700 31-May-19 18975258 30-Apr-19 18974821 30-Apr-19 18905927 31-Mar-19 19028296 30-Apr-19 19013074 30-Apr-19 18952060 31-Mar-19 18951116 31-Mar-19 18905896 28-Feb-19 18901749 28-Feb-19 18990624 30-Apr-19 18952296 31-Mar-19 19028056 30-Apr-19 19012985 30-Apr-19 18975695 30-Apr-19 18943458 31-Mar-19 18926529 31-Mar-19 18903033 28-Feb-19 19027936 30-Apr-19 19039567 31-May-19 19000541 30-Apr-19 18960301 31-Mar-19 18951588 31-Mar-19 18943981 31-Mar-19 18883033 28-Feb-19 18925429 31-Mar-19 18944504 31-Mar-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 3MM X 6CM || MODEL Number:M0035443060 || 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