Allegiance Esmark 6" x 144" Bandage, Latex Free, Sterile 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 International Medsurg Connection, 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
    36169
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1530-06
  • 사례 시작날짜
    2006-08-16
  • 사례 출판 날짜
    2006-09-29
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2007-01-24
  • 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 - Product Code MHW
  • 원인
    The bandages labeled as sterile had not been sterilized prior to distribution.
  • 조치
    International Medsurg Connection recalled the Esmark Bandages from Cardinal Health by telephone call on 8/16/06 and follow-up letter dated 8/24/06. The account was informed that some of the product may not have been sterilized even though it was labeled as sterile, and was requested to cease distribution of the affected lots, return the product to IMC and notify their customers to the retail level. Cardinal Health in turn notified their customers by letter dated 8/24/06, addressed to the Director of Materials Management, informing them of the possible non-sterilization of the product. Hospitals were requested to contact Cardinal Customer Service at 800-964-5227 to arrange for product return and credit or replacement of all product. All other customers were directed to call 1-888-444-5440 for product return and replacement. All questions were directed to Cardinal Quality Systems at 800-292-9332 or Mr. Manny Gupta at International Medsurg Connection at 847-619-9929.

Device

  • 모델명 / 제조번호(시리얼번호)
    Catalog 24593-064A, lot 06-2071-1
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide
  • 제품 설명
    Allegiance Esmark 6' x 144' Bandage, Latex Free, Sterile; 36 bandages per case; Individually wrapped for single patient use, Contents Sterile if Unopened, Undamaged; Distributed by Cardinal Health, McGaw Park, IL 60085-8787, Made in Malaysia; Catalog 24593-064A
  • Manufacturer

Manufacturer