Events

EZ Clean Disposable Laparoscopic Electrode 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Megadyne Medical Products, Inc. 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
    65995
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2097-2013
  • 사례 시작날짜
    2013-08-07
  • 사례 출판 날짜
    2013-08-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-01-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121166
  • 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
    Megadyne medical products is recalling certain lots of e-z clean, l-wire laproscopic electrode standard stem and split stem due to potential breach of insulation.
  • 조치
    Megadyne sent an Urgent: Medical Device Recall Field Safety Notice dated August 7, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customer were also notified with follow-up phone calls and email beginning on August 7, 2013. Customers were instructed to examine their stock immediately to determine if you have any of the products from the affected lots on hand. If so, please remove form service/discontinue use and contact Megadyne Customer Service at 1 (801) 576-9669 or (800) 747-6110 (USA) for return authorization and replacement or credit.

Device

EZ Clean Disposable Laparoscopic Electrode
  • 모델명 / 제조번호(시리얼번호)
    Model: 0100L, Lots: 131508, 131945, 132167, 132396 Model: 0100LS, Lots: 131509, 131946, 132058
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Class II Recall - Worldwide Distribution - US including the states of CA, HI, IL, MN, NC, NJ, OH, PA, TX, UT and VA.
  • 제품 설명
    E-Z Clean¿ Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Sterile. RX ONLY. This product is packaged individually in a chevron Tyvek¿ - polyester peel pouch, 6 pouches per box. || The E-Z Clean laparoscopic electrode is intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during laparoscopic surgical procedures. This device is intended to be used whenever monopolar electrosurgical cutting and coagulation are indicated.
  • Manufacturer
    Megadyne Medical Products, Inc.

Manufacturer

Megadyne Medical Products, Inc.
  • 제조사 주소
    Megadyne Medical Products, Inc., 11506 South State Street, Draper UT 84020-9453
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA