Events

Device Recall Integra Bilayer Matrix Wound Dressing 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Integra LifeSciences 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
    51402
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1174-2009
  • 사례 시작날짜
    2009-03-10
  • 사례 출판 날짜
    2009-04-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-06-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80200
  • 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
    Wound Dressing - Product Code FRO
  • 원인
    Package seal integrity: integra became aware of the potential of open seals in the foil pouch of the integra bilayer matrix wound dressings.
  • 조치
    Urgent: Product Recall Notification letters, dated March 10, 2009, were sent out by first class mail to all consignees. The letters asked consignees to quarantine any stock on hand and contact their local Integra Sales Representative for further assistance and for arrangement of product returns. Consignees also need to complete and return the "Recall Acknowledgement and Return Form" indicating whether or not they possess any affected product. Additional questions should be directed to Judith O'Grady at 609-936-2311.

Device

Device Recall Integra Bilayer Matrix Wound Dressing
  • 모델명 / 제조번호(시리얼번호)
    Lot number 105BA0105205
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution -- including states of CA, FL, MN, TX, NC, GA, NY, OH, MI, NE, and PA.
  • 제품 설명
    Integra Bilayer Matrix Wound Dressing, 8 in X 10 in (20 cm x 25 cm); Non-pyrogenic, Do not Re sterilize, Store flat at room temperature, Avoid Excessive heat, Avoid freezing. Sterile. Catalog number BMW810. || Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536, USA.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.