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-2167-2016
  • 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=147555
  • 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: M0035431030;  Lot Number/Expiration Date: 18801491 31-Jan-19 18757273 31-Dec-18 18709428 30-Nov-18 18602133 30-Sep-18 18523870 31-Jul-18 18802806 31-Jan-19 18664601 31-Oct-18 18569137 31-Aug-18 18517839 31-Jul-18 18486090 31-Jul-18 18842022 31-Jan-19 18651923 31-Oct-18 18651865 31-Oct-18 18607288 30-Sep-18 18518071 31-Jul-18 18774611 31-Dec-18 18762227 31-Dec-18 18637042 31-Oct-18 18564861 31-Aug-18 18843756 28-Feb-19 18842889 31-Jan-19 18781019 31-Jan-19 18651981 31-Oct-18 18546861 31-Aug-18 18447942 30-Jun-18 18830688 31-Jan-19 18815198 31-Jan-19 18814328 31-Jan-19 18736978 30-Nov-18 18592210 30-Sep-18 18517955 31-Jul-18 18414488 31-May-18 18829659 31-Jan-19 18583312 31-Aug-18 18984903 30-Apr-19 19050397 31-May-19 18883354 28-Feb-19 18911821 31-Mar-19 19041285 30-Apr-19 18944244 31-Mar-19 18922785 31-Mar-19 18902333 28-Feb-19 18911418 31-Mar-19 18857263 28-Feb-19 18973207 30-Apr-19 19041807 30-Apr-19 19065916 31-May-19 19063344 31-May-19 18901691 28-Feb-19 19074243 31-May-19 19049355 31-May-19 19042329 31-May-19 19005113 30-Apr-19 18944767 31-Mar-19 18973553 30-Apr-19 18943198 31-Mar-19 18943721 31-Mar-19 19042851 31-May-19 18855184 28-Feb-19 19048313 31-May-19 18972861 30-Apr-19 18953849 31-Mar-19 18912224 31-Mar-19 19005171 30-Apr-19 18902975 28-Feb-19 18912627 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 HELICAL NANO 1 MM X 3 CM || MODEL Number:M0035431030 || 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