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-2173-2016
  • 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=147563
  • 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: M0035442040:  Lot Number/Expiration Date: 18824889 31-Jan-19 18789584 31-Jan-19 18715147 30-Nov-18 18654621 31-Oct-18 18583663 31-Aug-18 18779217 31-Dec-18 18771773 31-Dec-18 18758989 31-Dec-18 18715561 30-Nov-18 18567945 31-Aug-18 18583694 30-Sep-18 18489927 31-Jul-18 18456251 30-Jun-18 18456101 30-Jun-18 18779279 31-Dec-18 18789344 31-Jan-19 18771711 31-Dec-18 18715383 30-Nov-18 18679151 30-Nov-18 18568131 31-Aug-18 18470407 30-Jun-18 18818239 31-Jan-19 18810301 31-Jan-19 18721156 30-Nov-18 18702459 30-Nov-18 18521395 31-Jul-18 18824769 31-Jan-19 18779248 31-Dec-18 18702490 30-Nov-18 18654590 31-Oct-18 18436562 30-Jun-18 18825009 31-Jan-19 18818208 31-Jan-19 18810061 31-Jan-19 18702552 30-Nov-18 18741929 30-Nov-18 18667537 31-Oct-18 18567883 31-Aug-18 18456191 30-Jun-18 18440768 30-Jun-18 18824649 31-Jan-19 18810181 31-Jan-19 18809941 31-Jan-19 18758869 31-Dec-18 18741991 30-Nov-18 18741898 30-Nov-18 18568007 31-Aug-18 18470287 30-Jun-18 18440708 30-Jun-18 18393710 31-May-18 18818177 31-Jan-19 18789464 31-Jan-19 18759109 31-Dec-18 18727865 30-Nov-18 18727745 30-Nov-18 18727625 30-Nov-18 18679089 30-Nov-18 18679120 30-Nov-18 18654528 31-Oct-18 18643778 31-Oct-18 18567914 31-Aug-18 18583725 30-Sep-18 18489834 31-Jul-18 19029955 30-Apr-19 19054722 31-May-19 19029924 30-Apr-19 19045373 31-May-19 19045249 31-May-19 19014943 30-Apr-19 18881427 28-Feb-19 18881017 28-Feb-19 18990009 30-Apr-19 19014850 30-Apr-19 18950447 31-Mar-19 18881632 28-Feb-19 18932694 31-Mar-19 18946218 31-Mar-19 19054784 31-May-19 19045404 31-May-19 19065216 31-May-19 18977548 30-Apr-19 18977459 30-Apr-19 18977370 30-Apr-19 18932725 31-Mar-19 19054660 31-May-19 19014757 30-Apr-19 18896432 28-Feb-19 18847681 31-Jan-19 19071276 31-May-19 19071040 31-May-19 19071512 31-May-19 19014881 30-Apr-19 19014819 30-Apr-19 18961269 31-Mar-19 18950385 31-Mar-19 19045342 31-May-19 18932663 31-Mar-19 18932632 31-Mar-19 18896699 28-Feb-19 18896610 28-Feb-19 18864702 28-Feb-19 18881222 28-Feb-19 18848037 28-Feb-19 19054846 31-May-19 19029893 30-Apr-19 19014788 30-Apr-19 18950323 31-Mar-19 18896521 28-Feb-19 18915222 28-Feb-19 18864775 28-Feb-19 18847859 31-Jan-19 19054908 31-May-19 19045311 31-May-19 18977637 30-Apr-19 19014974 30-Apr-19 18946365 31-Mar-19 18915017 28-Feb-19 18914812 28-Feb-19 18864836 28-Feb-19 18848215 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 2MM X 4CM || MODEL Number:M0035442040 || 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