Events

AngioSeal Evolution 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Terumo Medical Corp 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
    80242
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2337-2018
  • 사례 시작날짜
    2018-04-09
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164942
  • 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, hemostasis, vascular - Product Code MGB
  • 원인
    Two lots of product were released for distribution prior to the completion of all required validation and lot acceptance activities. although sterile, products from these lots may not function as intended and therefore should not be used.
  • 조치
    On April 9, 2018, the firm sent Urgent Voluntary Medical Device Recall letters and Inventory Confirmation Forms to customers via FedEx. The letter described the product issue. Customers were asked to: 1. Review your Angio-Seal Evolution inventory immediately to identify and isolate affected inventory in order to prevent future use. 2. Your Terumo Territory Manager will visit your facility to confirm product inventory and assist you in completing the enclosed Recall Acknowledgement/ Inventory Confirmation Form. This required documentation, along with the enclosed Fed-Ex product shipment labels will facilitate your return of affected Angio-Seal Evolution product to Terumo Medical Corporation.

Device

AngioSeal Evolution
  • 모델명 / 제조번호(시리얼번호)
    5980075, 5980077
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Distributed to accounts in AL, CA, FL, IA, IN, MI, MO, NC, NY, SD, TN, and TX.
  • 제품 설명
    Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135
  • Manufacturer
    Terumo Medical Corp

Manufacturer

Terumo Medical Corp
  • 제조사 주소
    Terumo Medical Corp, 2101 Cottontail Ln, Somerset NJ 08873-1277
  • 제조사 모회사 (2017)
    Terumo Corp.
  • Source
    USFDA