Events

Device Recall Fernotrac 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ferno-Washington 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
    73641
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1604-2016
  • 사례 시작날짜
    2016-03-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-08-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144677
  • 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
    Stretcher, patient restraint - Product Code NZD
  • 원인
    On march 9, 2016, the firm was contacted regarding the possibility of incorrect labeling on the outside poly- bag of the traction splint straps. the firm investigated and determined its supplier had labeled the outside packaging for the pediatric and adult traction splints straps incorrectly. the packaging labeled adult contained a pediatric splint strap and the packaging labeled pediatric conta.
  • 조치
    Ferno-Washington, Inc , has contacted all customers via telephone on March 10, 2016. All products will be replaced with new products. For further questions, please call: (937) 283-2885.

Device

Device Recall Fernotrac
  • 모델명 / 제조번호(시리얼번호)
    Strap Kit Adult Model 444
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Distribution to the states of : AK ,AZ ,CA, CO, FL ,GA ,HI, IL ,IN ,KY ,MA ,MI ,MS ,NC ,NE ,NJ ,NY ,OH,ON,TX ,VA ,WI , and WV. There are no government accounts for this recall. There is one Canadian account for this recall. There are no Mexican accounts for this recall. and to the countries of : UAE, MALAYSIA, UNITED KINGDOM, SLOVAKIA, SOUTH AFRICA, QATAR and AUSTRALIA..
  • 제품 설명
    Poly-bags containing the strap labeled with "Adult" sticker. || Each strap kit contains adjustable length leg straps, ankle wrap, a thigh pad and a heel stand. The strap kits are applied to the traction splint frame to immobilize and provide traction for a patients leg.
  • Manufacturer
    Ferno-Washington Inc

Manufacturer

Ferno-Washington Inc
  • 제조사 주소
    Ferno-Washington Inc, 70 Weil Way, Wilmington OH 45177-9371
  • 제조사 모회사 (2017)
    Ferno-Washington Inc.
  • Source
    USFDA