Events

Device Recall INTEGRA NEUROSCIENCESStep Down ConnectorNon Sterile for Single Use Only 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Integra Neurosciences PR, Inc. 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
    60599
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1051-2012
  • 사례 시작날짜
    2011-11-28
  • 사례 출판 날짜
    2012-02-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-10-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106497
  • 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
    Shunt, central nervous system and components - Product Code JXG
  • 원인
    The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility.
  • 조치
    Integra sent an Urgent Product Recall Notification letter dated November 28, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to fill out and sign the attached Recall Acknowledgement Form noting the part numbers, lot numbers and quantity of the affected product in their inventory. Customers were asked to contact Integra LifeSciences Corporation International Customers Service at 609-936-5400 to arrange for Returns. If customers do not have any of the affected product in their inventory they are required to complete and sign the form and indicate they have NO affected product in their inventory. Customers should fax or email their Recall Acknowledgement Form to: 609-750-4259 or LAPAC_CS@Integralife.com For questions call 609-936-2495.

Device

Device Recall INTEGRA NEUROSCIENCESStep Down ConnectorNon Sterile for Single Use Only
  • 모델명 / 제조번호(시리얼번호)
    1011261, 1020752, 1020887, 1021660, 1030180, 1031438, 1031740, 1041562, 1042443, 1050389, 1050897, 1052789, 1052981, 1053298, 1061717, 1072920, 1073554, 1081985, 1082859, 1090536, 1091830, 1092604
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Austria, Canada, Italy, Australia
  • 제품 설명
    "***REF NL86004-01***INTEGRA NEUROSCIENCES***Step Down Connector***Non Sterile for Single Use Only***Small OD .047", Large OD .058"***Plainsboro, NJ***" || Step down connector to be secure with ligature
  • Manufacturer
    Integra Neurosciences PR, Inc.

Manufacturer

Integra Neurosciences PR, Inc.
  • 제조사 주소
    Integra Neurosciences PR, Inc., Carr 402 Norte Km 1.2, Anasco PR 00610
  • Source
    USFDA