Events

Device Recall Convertors Robotic Drape with Attached Leggings; Product is packaged as Single Sterile Drape 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cardinal Health 200, LLC 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
    77917
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3046-2017
  • 사례 시작날짜
    2017-07-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-12-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158213
  • 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
    Sudan iv - Product Code KKK
  • 원인
    Product 29474 lavh drape was packaged as 29574 robotic drape with leggings.
  • 조치
    Cardinal Health sent an Urgent: Product Recall letter dated July 28, 2017. Distributors are requested to notify their customers of the action. An acknowledgement form is included as part of the notification. Responses are tracked. All returned product will be quarantined. All inventory recovered from the field will be destroyed. For further questions, please call (800) 292-9332.

Device

Device Recall Convertors Robotic Drape with Attached Leggings; Product is packaged as Single Ste...
  • 모델명 / 제조번호(시리얼번호)
    Lot number 17DAH349
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Distribution to the states of : NC, UT, OR, NY,TX, GA, NJ and FL.
  • 제품 설명
    Convertors Robotic Drape with Attached Leggings; Product is packaged as Single Sterile Drape/8 per Case
  • Manufacturer
    Cardinal Health 200, LLC

Manufacturer

Cardinal Health 200, LLC
  • 제조사 주소
    Cardinal Health 200, LLC, 1500 S Waukegan Rd, Waukegan IL 60085-6728
  • 제조사 모회사 (2017)
    Cardinal Health
  • Source
    USFDA