Events

Device Recall MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Gyrus Acmi, Incorporated 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
    65255
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1439-2013
  • 사례 시작날짜
    2013-05-24
  • 사례 출판 날짜
    2013-05-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-05-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118384
  • 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
    Instrument, ent manual surgical - Product Code LRC
  • 원인
    Lack of sterility assurance.
  • 조치
    Cyrus ACMI notified their direct accounts of the recall by Priority Mail with delivery confirmation on May 24, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory and immediately cease any further use of any affected product they may have, remove it from inventory, and quarantine it until they ship it back to the firm. For questions customers were instructed to contact their Olympus customer service representative at 1-800-848-9024 to obtain a Returned Goods Authorization so that they may return the product with no charge to them. Customers were asked to note on the enclosed questionnaire that they have received this information and fax it to 484-896-7128. For questions regarding this recall call 508-804-2739.

Device

Device Recall MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE
  • 모델명 / 제조번호(시리얼번호)
    JC477666
  • 의료기기 분류등급
    Ear, Nose, and Throat Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and countries of: Canada and United Kingdom.
  • 제품 설명
    GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104 || Disposable myringotomy knife intended to perforate the tympanic membrane to allow the placement of a bent tube or to directly provide ventilation or drainage of the middle ear.
  • Manufacturer
    Gyrus Acmi, Incorporated

Manufacturer

Gyrus Acmi, Incorporated
  • 제조사 주소
    Gyrus Acmi, Incorporated, 136 Turnpike Road, Southborough MA 01772-2118
  • 제조사 모회사 (2017)
    Olympus Corporation
  • Source
    USFDA