Device Recall Esmark Elastic Bandage, 4" x 3 yards 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cardinal Health 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
    50198
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0616-2009
  • 사례 시작날짜
    2008-11-18
  • 사례 출판 날짜
    2009-01-16
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2009-11-04
  • 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
    Bandage, elastic - Product Code FQM
  • 원인
    The natural rubber latex bandages were mislabeled as latex free.
  • 조치
    A recall letter dated 11/17/08 was issued to the Directors of Materials Management and sent via DHL 2-day service on 11/18/08. Accounts were advised that the elastic bandages containing latex were mislabeled as latex free. Customers were requested to return their inventories of the affected product to Cardinal Health for credit or replacement by calling the Presource Customer Sales Operations Group at 800-766-0706 for return instructions. Customers were also requested to complete the enclosed Cardinal Customer Acknowledgement form by indicating the amount of affected product being returned and fax it to 847-689-9101. Please direct questions to Quality Systems, Professional Services at 800-292-9332.

Device

  • 모델명 / 제조번호(시리얼번호)
    Catalog number 23580-043: Work order numbers 310652, 316815, 324060 and 327413.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution including USA, Guam and Korea.
  • 제품 설명
    Esmark Elastic Bandage, 4" x 3 yards, sterile, for single use only, latex free. Distributed by Cardinal Health, McGaw Park, IL 60085-6787. || The device is used to promote blood flow from the extremities by compressing the superficial vessels.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Cardinal Health, 1430 Waukegan Rd, Mc Gaw Park IL 60085-6726
  • 제조사 모회사 (2017)
  • Source
    USFDA