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-2160-2016
  • 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=147540
  • 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: M0035421020: Lot Number/Expiration Date: 18825272 31-Jan-19 18811666 31-Jan-19 18819711 31-Jan-19 18790659 31-Jan-19 18701550 30-Nov-18 18628881 31-Oct-18 18598937 30-Sep-18 18562915 31-Aug-18 18582507 30-Sep-18 18582275 31-Aug-18 18819885 31-Jan-19 18811840 31-Jan-19 18742370 30-Nov-18 18714594 30-Nov-18 18723922 30-Nov-18 18701782 30-Nov-18 18701608 30-Nov-18 18677925 30-Nov-18 18657200 31-Oct-18 18667185 31-Oct-18 18667069 31-Oct-18 18647521 31-Oct-18 18599227 30-Sep-18 18582565 30-Sep-18 18553961 31-Aug-18 18790775 31-Jan-19 18790543 31-Jan-19 18742602 31-Dec-18 18647347 31-Oct-18 18604218 30-Sep-18 18585521 31-Aug-18 18515100 31-Jul-18 18825330 31-Jan-19 18790717 31-Jan-19 18723864 30-Nov-18 18742428 31-Dec-18 18714478 30-Nov-18 18729520 30-Nov-18 18677693 30-Nov-18 18657142 31-Oct-18 18638318 31-Oct-18 18647405 31-Oct-18 18604160 30-Sep-18 18825156 31-Jan-19 18825214 31-Jan-19 18819827 31-Jan-19 18811724 31-Jan-19 18729346 30-Nov-18 18701724 30-Nov-18 18657316 31-Oct-18 18623511 30-Nov-18 18647463 31-Oct-18 18599053 30-Sep-18 18591050 30-Sep-18 18534835 31-Aug-18 18819769 31-Jan-19 18811608 31-Jan-19 18825098 31-Jan-19 18759488 31-Dec-18 18701434 30-Nov-18 18667011 31-Oct-18 18628939 31-Oct-18 18598879 30-Sep-18 18591108 30-Sep-18 18562741 31-Aug-18 18534777 31-Aug-18 18790485 31-Jan-19 18701492 30-Nov-18 18666953 31-Oct-18 18638260 31-Oct-18 18598995 30-Sep-18 18599111 30-Sep-18 18554135 31-Aug-18 18515042 31-Jul-18 18469498 31-Jul-18 18447937 30-Jun-18 18811550 31-Jan-19 18790601 31-Jan-19 18677809 30-Nov-18 18591166 30-Sep-18 18590992 30-Sep-18 18582449 30-Sep-18 18582391 31-Aug-18 18582333 31-Aug-18 18554019 31-Aug-18 18515274 31-Jul-18 18488746 31-Jul-18 18965760 31-Mar-19 19030868 30-Apr-19 19030690 30-Apr-19 19044166 31-May-19 18977312 30-Apr-19 19071102 31-May-19 19013933 30-Apr-19 19071338 31-May-19 18977223 30-Apr-19 18946958 31-Mar-19 18896552 28-Feb-19 18916270 31-Mar-19 19082881 31-May-19 19030512 31-May-19 19030601 30-Apr-19 19030423 30-Apr-19 19070866 31-May-19 19014107 30-Apr-19 18896730 28-Feb-19 18916212 31-Mar-19 18871405 28-Feb-19 19044108 31-May-19 18998870 30-Apr-19 18916328 31-Mar-19 18896641 28-Feb-19  18847217 28-Feb-19 19082823 31-May-19 18998696 30-Apr-19 18998754 30-Apr-19 18956299 31-Mar-19 18946869 31-Mar-19 18887631 28-Feb-19 18916444 31-Mar-19 19054107 31-May-19 19043992 31-May-19 19013875 30-Apr-19 18947047 31-Mar-19 18965876 30-Apr-19 18977579 30-Apr-19 18946780 31-Mar-19 18871639 28-Feb-19 19013991 30-Apr-19 18965992 31-Mar-19 18977490 30-Apr-19 18946691 31-Mar-19 18871880 28-Feb-19 19053759 31-May-19 19053585 31-May-19 19030779 30-Apr-19 19014049 30-Apr-19 18998812 30-Apr-19 19065042 31-May-19 18965644 31-Mar-19 18931829 31-Mar-19 18931597 31-Mar-19 18878088 28-Feb-19 18846985 28-Feb-19 19053933 31-May-19 19044050 31-May-19 18956241 31-Mar-19 18887747 28-Feb-19 18931365 31-Mar-19 18878146 28-Feb-19 18916386 31-Mar-19 18916502 31-Mar-19 18872114 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 MM X 2 CM || MODEL Number: M0035421020 || 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