Events

Device Recall GENERAL PROCEDURE KIT 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Integra Life Sciences Corporation 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
    52683
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2101-2009
  • 사례 시작날짜
    2009-07-13
  • 사례 출판 날짜
    2009-09-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-10-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83712
  • 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
    Syringe, piston - Product Code CAZ
  • 원인
    Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
  • 조치
    Consignees were notified by telephone on July 09, 2009 and by "Urgent Medical Device Recall" letter on July 13, 2009. Customers were instructed to immediately examine inventory, cease use and distribution of any affected product and to contact Integra Pain Management Customer Service by calling 1-800-241-2210 to arrange for return and replacement. Refer questions to Integra Pain Management by calling 1-800-241-2210.

Device

Device Recall GENERAL PROCEDURE KIT
  • 모델명 / 제조번호(시리얼번호)
    Lot number W0905257
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US (states of AK, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IN, KY, ME, MO, NC, NJ, NV, NY, OH, OK, PA, RI, SD, ST, TX and UT), Belgium and Japan.
  • 제품 설명
    Universal Painpak, Disposable, Convenience Kit, Reorder Number SS3278, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. || Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures.
  • Manufacturer
    Integra Life Sciences Corporation

Manufacturer

Integra Life Sciences Corporation