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-2169-2016
  • 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=147557
  • 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: M0035431520:  Lot Number/Expiration Date: 18784673 31-Jan-19 18723226 30-Nov-18 18686302 30-Nov-18 18637332 31-Oct-18 18627687 31-Oct-18 18569824 31-Aug-18 18453278 30-Jun-18 18391505 31-May-18 18769932 31-Dec-18 18735994 30-Nov-18 18710356 30-Nov-18 18652851 31-Oct-18 18801847 31-Jan-19 18755945 31-Dec-18 18602481 30-Sep-18 18832966 28-Feb-19 18843005 28-Feb-19 18630099 31-Oct-18 18510994 31-Jul-18 18495363 31-Jul-18 18484141 31-Jul-18 18803162 31-Jan-19 18786297 31-Jan-19 18754879 31-Dec-18 18734778 30-Nov-18 18602423 30-Sep-18 18585290 31-Aug-18 18450430 30-Jun-18 18769816 31-Dec-18 18785485 31-Jan-19 18637274 31-Oct-18 18511110 31-Jul-18 18465901 30-Jun-18 18769700 31-Dec-18 18746995 31-Dec-18 18725103 30-Nov-18 18694228 30-Nov-18 18686012 30-Nov-18 18665561 31-Oct-18 18607752 30-Sep-18 18449575 30-Jun-18 18832355 28-Feb-19 18831744 31-Jan-19 18842138 28-Feb-19 18732878 30-Nov-18 18637216 31-Oct-18 18584252 31-Aug-18 18569882 31-Aug-18 18569766 31-Aug-18 18523410 31-Jul-18 19033487 30-Apr-19 18984845 30-Apr-19 18972140 30-Apr-19 18861952 28-Feb-19 18878607 28-Feb-19 19063170 31-May-19 18923191 31-Mar-19 18897527 28-Feb-19 18897185 28-Feb-19 18910290 31-Mar-19 19032199 30-Apr-19 19002213 30-Apr-19 19002155 30-Apr-19 18950942 31-Mar-19 18897698 28-Feb-19 18858983 28-Feb-19 19031329 30-Apr-19 19031909 30-Apr-19 19002271 30-Apr-19 18951058 31-Mar-19 18950884 31-Mar-19 18896843 28-Feb-19 18897014 28-Feb-19 18879010 28-Feb-19 18909942 31-Mar-19 18910638 31-Mar-19 18843872 28-Feb-19 19031619 30-Apr-19 19002329 30-Apr-19 18878204 28-Feb-19 18886556 28-Feb-19 18938172 31-Mar-19 18939594 31-Mar-19 18951000 31-Mar-19 18897356 28-Feb-19 18885142 28-Feb-19 18971589 30-Apr-19 18950826 31-Mar-19 18860449 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 HELICAL NANO 1.5 MM X 2 CM || MODEL Number:M0035431520 || 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