Posey Connecting Strap/Belt 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 J T Posey Company 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
    52711
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2262-2009
  • 사례 시작날짜
    2009-04-20
  • 사례 출판 날짜
    2009-09-22
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-04-11
  • 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
    Restraint, protective - Product Code FMQ
  • 원인
    Posey has initiated a recall on certain posey product units which were manufactured using an incorrect key lock buckle. the intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.
  • 조치
    JT Posey Company issued an "Urgent Medical Device Recall (Removal)" letter dated May 14, 2009 informing customers of the affected products. Any used and/or existing inventory subject to this recall is requested to be returned to Posey including the Recall Reply Fax-Back Form. For further questions, contact your local sales representative or JT Posey Company at 1-800-447-6739 extension 111.

Device

  • 모델명 / 제조번호(시리얼번호)
    All Product with Catalog Number 235036 manufactured between Ferbruary 2009 and April 2009.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Class II Recall - Worldwide Distribution -- United States, Canada, France, Belgium and the Netherlands.
  • 제품 설명
    Posey Connecting Strap/Belt, Polypropylene, 36" (235036). || Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.
  • Manufacturer

Manufacturer

  • 제조사 주소
    J T Posey Company, 5635 Peck Rd, Arcadia CA 91006
  • 제조사 모회사 (2017)
  • Source
    USFDA