Events

Device Recall MediVac Speciment Sock 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cardinal Health 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
    58028
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1852-2011
  • 사례 시작날짜
    2011-02-18
  • 사례 출판 날짜
    2011-03-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-10-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98028
  • 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
    Container, specimen, non-sterile - Product Code NNI
  • 원인
    In one lot of product (lot# 1091745), the label for the small version of the sock (catalog number 65652-123) was improperly used for the larger version of the product (65652-124).
  • 조치
    On February 18, 2011 Cardinal Health sent a consignee letter with the following instruction: 1) Quarantine either Catalog Number with the inticated Lot Number. 2) Contact the appropiate Customer Service group for return instructions: Hospital - 800-964-5227 Federal Government - 800-444-1166 Distributirs - 800-635-6021 All other customers - 888-444-5440 3) Return the enclosed acknowledge form via fax to 847-689-9101, even if you do not have affected product, as Cardinal Health is required to confirm receipt of this notification from you, and to prevent further notices. 4) Notify any customer to whom you may have distributed product affected by this recall.

Device

Device Recall MediVac Speciment Sock
  • 모델명 / 제조번호(시리얼번호)
    65652-123 and 65652-124 / 1091745
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AL, AR, AZ. CA. CO,, CT, DC, DE, FL, GA, HI, IA, ID,IL,IM,KS, KY, LA, MA, MD, ME. MI MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, & Puerto Rico - and the country of Canada.
  • 제품 설명
    Large Port Specimen Sock, used to convert the pour/accessory port of a Cardinal Suction canister into a specimen retainer. The sock is used as an accessory in a suction collection system. Its placed in a suction canister to remove solids from the liquid aspirated during surgery. The solids may consist of patient tissue that are then sent to pathology or retained for other purposes. There is no direct contact between this device and the patient. || Large Port Specimen Sock, used to convert the pour/accessory port of a Cardinal Suction canister into a specimen retainer. The sock is used as an accessory in a suction collection system. Its placed in a suction canister to remove solids from the liquid aspirated during surgery. The solids may consist of patient tissue that are then sent to pathology or retained for other purposes. There is no direct contact between this device and the patient.
  • Manufacturer
    Cardinal Health Inc

Manufacturer

Cardinal Health Inc
  • 제조사 주소
    Cardinal Health Inc, 7000 Cardinal Pl, Dublin OH 43017-1091
  • 제조사 모회사 (2017)
    Cardinal Health
  • Source
    USFDA