Events

Device Recall Centrica 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Sanarus Medical 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
    26324
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0935-03
  • 사례 시작날짜
    2003-05-13
  • 사례 출판 날짜
    2003-06-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2003-09-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27510
  • 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
    Instrument, Biopsy - Product Code KNW
  • 원인
    Recent 'pre-tests' show that argon gas has the potential to escape from the device during a biopsy procedure.
  • 조치
    On 5/13/03, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected devices and providing instructions on the recall.

Device

Device Recall Centrica
  • 모델명 / 제조번호(시리얼번호)
    Lot #: 28090403, 03-0085, 03-0086, C030401
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was released for distribution to 10 consignees. 83 units from the lot had been shipped to consignees. The U.S. States include: MD, TN, TX, OH, and IL. The recall was appropriately extended to the user level; i.e., clinics, hospitals and medical centers who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
  • 제품 설명
    Sanarus brand Centrica¿ Rotational Core Biopsy medical device, Model/Product Code: CD-0500 (single Device); CD-1000 (5 pack)
  • Manufacturer
    Sanarus Medical Inc

Manufacturer

Sanarus Medical Inc
  • 제조사 주소
    Sanarus Medical Inc, 5880 West Las Positas Suite 52, Pleasanton CA 95488
  • Source
    USFDA