Events

Device Recall Medline Angio Drape Pack RadiologyLF 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medline Industries 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
    63739
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0568-2013
  • 사례 시작날짜
    2012-11-08
  • 사례 출판 날짜
    2012-12-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-12-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114684
  • 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
    General surgery tray (kit) - Product Code LRO
  • 원인
    The non-sterile waste bag component in the custom pack was attached to the outside of the pack in its own packaging. the product was not labeled or identified as sterile, but was assumed to be sterile by the customer.
  • 조치
    The firm, Medline Industries, Inc., telephoned the consignee/customer on November 8, 2012. The phone call informed the customer of the product, problem and actions to be taken. The customer was instructed to inform the staff at the facility not to use the pack until it had been reworked to replace the non-sterile waste bag with the sterile equivalent. It was also noted that the product does not need to be returned as it is being replaced directly at the facility. If you have any question call 847-837-2759 or email lsimmons@medline.com.

Device

Device Recall Medline Angio Drape Pack RadiologyLF
  • 모델명 / 제조번호(시리얼번호)
    Reorder #DYNJ35993D, lot numbers 12HD2126, exp. 5/31/2015; 12IB5014, exp. 7/31/2015 and 12JB8311, exp. 5/31/2015
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: New York only.
  • 제품 설명
    Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescription procedure pack, including a waste bag, for use by the Interventional Radiology Department; Packaged for Medline Industries, Inc.; Reorder #DYNJ35993D || This custom pack includes components necessary for a specific procedure.
  • Manufacturer
    Medline Industries Inc

Manufacturer

Medline Industries Inc
  • 제조사 주소
    Medline Industries Inc, 1 Medline Pl, Mundelein IL 60060
  • 제조사 모회사 (2017)
    Medline Industries Inc.
  • Source
    USFDA