Events

Device Recall Stryker CBCII ConstaVac Blood Conservation System with Quick Disconnect and 1/4in. (6.4mm) PVC Drain 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Instruments Div. of Stryker 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
    54149
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0733-2010
  • 사례 시작날짜
    2009-11-12
  • 사례 출판 날짜
    2010-01-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-10-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87648
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • 데이터 추가 비고
    Apparatus, autotransfusion - Product Code cac
  • 원인
    The product may not be sterile due to package not being intact.
  • 조치
    Stryker issued a "Medical Device Recall Notification" via email to foreign consignees dated November 12, 2009. Stryker further issued recall letters via overnight mail to domestic consginees beginning November 20, 2009. These notifications informed consignees of the affected devices instructing them to destroy all affected product and return a completed Business Reply Form to the firm. For further information, contact Stryker Instruments at 1-800-800-4236 extension 3808.

Device

Device Recall Stryker CBCII ConstaVac Blood Conservation System with Quick Disconnect and 1/4in....
  • 모델명 / 제조번호(시리얼번호)
    serial numbers 07310012 through 09159012
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution.
  • 제품 설명
    Stryker CBCII ConstaVac Blood Conservation System with Quick Disconnect and 1/4in. (6.4mm) PVC Drain, sterile, Stryker Instruments, Kalamazoo, MI REF 225-28-916. || Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • 제조사 주소
    Stryker Instruments Div. of Stryker Corporation, 4100 E. Milham Ave., Kalamazoo MI 49001
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA