Centurion 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Centurion Medical Products Corporation 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
    70081
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0942-2015
  • 사례 시작날짜
    2014-10-23
  • 사례 출판 날짜
    2015-01-08
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2015-06-08
  • 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
    Cardiovascular surgical instruments tray (kit) - Product Code OFA
  • 원인
    According to the recall notice received from hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. hospira identified the particulate as human hair, embedded in and attached to a pinched area of the stopper.
  • 조치
    Centurion sent an Urgent Product Recall Notice dated October 23, 2014, to al affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify and remove all affected inventory that may be in their possession and to forward a copy of thie noctice to any cusotmers to whom the affected product may have been further distributed. Customers were asked to complete the enclosed accountability record whether not they have the product and fax to 517-546-3356. Customers with questions were instructed to call 517-546-5400 Ext. 1135. For questions regarding this recall call 517-546-5400, ext 1135.

Device

  • 모델명 / 제조번호(시리얼번호)
    CMP Kit code: CHT900 Lot numbers: 2014061950 and 2014070750 Expiration date, both lots: 2016-03
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including MA, IN, NY, GA, AL, PA, and RI.
  • 제품 설명
    Chest Tube Tray (Cardiovascular Surgical Instruments convenience kit)
  • Manufacturer

Manufacturer

  • 제조사 주소
    Centurion Medical Products Corporation, 100 Centurion Way, Williamston MI 48895-9086
  • 제조사 모회사 (2017)
  • Source
    USFDA