Pilling CenterAction Forceps 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Telefelx Medical 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
    45515
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0266-2008
  • 사례 시작날짜
    2007-10-31
  • 사례 출판 날짜
    2007-11-29
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2009-08-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Forceps - Product Code HTD
  • 원인
    The specified insulation is not present on the shaft of the devices, leaving a risk of arcing and/or damage to surrounding tissue.
  • 조치
    Consignees were notified by an Urgent Medical Device Recall letter on/about 11/1/2007. They were instructed to immediately cease use and distribution of the affected product and to return them to Teleflex Medical, Durham, NC. In addition, each were instructed to forward the letter if they had further distribution into institutional settings or to homecare patients and retrieve relevant product form those locations. An Acknowledgement & Stock Status Form was enclosed to be completed and faxed back to Teleflex Medical.

Device

  • 모델명 / 제조번호(시리얼번호)
    Date Codes: WW5, XX5, NN6, RR6, TT6, XX6, MM7, NN7, OO7, QQ7 and SS7
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide: USA including states of AL, AR, AZ, CA, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NY, NV, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV, and countries of Canada, France New Zealand and Singapore.
  • 제품 설명
    Pilling¿ Center-Action Forceps with Insulated Shafts- Serrated Grasping Jaws, Catalog Number: 505015, Non Sterile, Rx Only, (ALLIG GRASPING FCPS 30 CM INSUL), Manufactured for : Teleflex Medical, Research Triangle Park, NC 27709 USA
  • Manufacturer

Manufacturer

  • 제조사 주소
    Telefelx Medical, 2917 Weck Drive, Durham NC 27709
  • 제조사 모회사 (2017)
  • Source
    USFDA