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-2161-2016
  • 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=147541
  • 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: M0035421030: Lot Number/Expiration Date: 18604566 30-Sep-18 18488920 31-Jul-18 18807744 31-Jan-19 18807570 31-Jan-19 18677403 31-Oct-18 18666895 31-Oct-18 18654009 31-Oct-18 18647637 31-Oct-18 18629287 31-Oct-18 18542421 31-Aug-18 18554251 31-Aug-18 18469669 30-Jun-18 18462274 30-Jun-18 18462217 30-Jun-18 18393386 30-Apr-18 18814099 31-Jan-19 18788265 31-Jan-19 18769352 31-Dec-18 18714536 30-Nov-18 18701840 30-Nov-18 18677577 30-Nov-18 18677461 30-Nov-18 18629171 31-Oct-18 18604508 30-Sep-18 18582681 30-Sep-18 18535009 31-Aug-18 18426357 30-Jun-18 18714768 30-Nov-18 18714652 30-Nov-18 18629229 31-Oct-18 18554193 31-Aug-18 18701898 30-Nov-18 18730274 30-Nov-18 18677519 30-Nov-18 18653835 31-Oct-18 18831481 31-Jan-19 18769468 31-Dec-18 18714304 30-Nov-18 18807918 31-Jan-19 18714420 30-Nov-18 18654067 31-Oct-18 18638376 31-Oct-18 18590876 30-Sep-18 18604450 30-Sep-18 18488978 31-Jul-18 18469612 30-Jun-18 18831539 31-Jan-19 18788439 31-Jan-19 18736862 31-Dec-18 18736746 30-Nov-18 18666837 31-Oct-18 18666779 31-Oct-18 18653893 31-Oct-18 18604392 30-Sep-18 18542479 31-Aug-18 18931539 31-Mar-19 18901428 28-Feb-19 19048197 31-May-19 18945290 31-Mar-19 18931771 31-Mar-19 18846927 31-Jan-19 18909826 31-Mar-19 18887689 28-Feb-19 18887573 28-Feb-19 18847159 28-Feb-19 18976078 30-Apr-19 19025545 30-Apr-19 19043431 31-May-19 18975900 30-Apr-19 18975989 30-Apr-19 19067208 31-May-19 18954139 31-Mar-19 18961180 31-Mar-19 18961060 31-Mar-19 18945174 31-Mar-19 18931307 31-Mar-19 18847043 31-Jan-19 19025429 30-Apr-19 19048139 31-May-19 18945406 31-Mar-19 18901486 28-Feb-19 18909768 28-Feb-19 19043373 31-May-19 19012218 30-Apr-19 19012392 30-Apr-19 18976167 30-Apr-19 18854389 28-Feb-19 19012044 30-Apr-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 MM X 3 CM || MODEL Number: M0035421030 || 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