Device Recall monopolar pencil 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Olsen 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
    80080
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1941-2018
  • 사례 시작날짜
    2018-05-11
  • 사례 상황
    Open, Classified
  • 사례 국가
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • 원인
    Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.
  • 조치
    Symmetry initiated their recall via Urgent Medical Device Recall notices on 05/11/2018 sending faxes to accounts, as applicable; and, will also send the Notice via US certified mail, with return receipt requested, and will also send the Notice via e-mail to those customers for which it has a valid e-mail address (as applicable). All customers were asked to quarantine any products that reflect a breach of the seal area or any products that they do not wish to inspect immediately and promptly call (800) 251-3000 for a return material authorization (RMA) number to support the return of the impacted Products. All customers outside of the United States (OUS) will be provided with the Notice via postal mail and through Symmetrys Distributors in each country and requested to quarantine immediately and promptly call Symmetry's Distributors to support the return of any products that have a breach of the seal area or which the customer does not wish to inspect. Appropriate notifications will be sent to Health Authorities in Canada, European Union, and other countries that require notification of this recall.

Device

  • 모델명 / 제조번호(시리얼번호)
    all codes
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    Symmetry Olsen Monopolar Pencil: || (a) Button Switchpen, w/ Standard Needle Electrode REF 75505, QTY 50 || (b) Button Switchpen, w/ Standard Blade Electrode, REF 75530, QTY 50 || (c) Rocker Switchpen, w/ Standard Blade Electrode, REF 75610, QTY 50 || (d) Button Switchpen, w/ Extendable Blade Electrode, 10 mm Exposure, REF 75800, QTY 25 || (e) Button Switchpen, w/ Extendable Blade Electrode, 2 mm Exposure, REF 75810, QTY 25 || (f) Button Switchpen, w/ Extendable Needle Electrode, 2 mm Exposure, REF 75820, QTY 25 || (g) Foot Controlled Handle, w / Standard Blade electrode, REF 95012, QTY 100 || Designed to hold active electrodes.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Olsen Medical, 3230 Commerce Center Pl, Louisville KY 40211-1900
  • 제조사 모회사 (2017)
  • Source
    USFDA