Events

Juxta Lite 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Circaid 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
    55529
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1688-2010
  • 사례 시작날짜
    2010-04-20
  • 사례 출판 날짜
    2010-05-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-01-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91053
  • 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
    compression wrap - Product Code MDR
  • 원인
    Some systems in these lots have built-in pressure system lines with the incorrect amount of spacing. some systems in these lots had i inch space between each line with no tension applied. the system should have 1.25 inches of space. the correct spacing (1.25") is necessary to achieve the measured tension ranges. the incorrect spacing may result in the inability to achieve the correct tension level.
  • 조치
    CircAid Medical Products Important Device Product Recall letter dated Apr 20, 2010 was mailed to consignees describing problem, listing affected product and distribution dates. Customers were instructed to locate and return these Juxta-Lite Systems from stock and notify their customers A Retum Authorization number and contact name was provided. this listing for product returns.

Device

Juxta Lite
  • 모델명 / 제조번호(시리얼번호)
    All units sold between 2/1/10 and 4/14/10.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA, Japan, Canada, Netherlands
  • 제품 설명
    Juxta-Lite compression wrap XL Full Calf Long 33cm Length with Separate Medium AFW Catalog 23236117
  • Manufacturer
    Circaid Medical Products Inc

Manufacturer

Circaid Medical Products Inc
  • 제조사 주소
    Circaid Medical Products Inc, 9323 Chesapeake Dr Ste B1/B2, San Diego CA 92123
  • 제조사 모회사 (2017)
    Circaid Medical Products Inc.
  • Source
    USFDA