Events

Device Recall CENTURION V.A.D. TRAY 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
    58346
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2374-2011
  • 사례 시작날짜
    2011-03-31
  • 사례 출판 날짜
    2011-05-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-09-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99174
  • 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
    Kit, i.V. Start - Product Code MCY
  • 원인
    This voluntary sub-recall was initiated because the vials of bacteriostatic sodium chloride injection, usp, 0.9% utilized to make the products may contain visible particulates.
  • 조치
    Centurion Medical Products Corporation issued press on April 1, 2011, and sent an Urgent Voluntary Recall letter dated March 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the kits immediately and instructions were provided for the return of the kits. Customers were also asked to complete a form to fax or email back to the firm regarding the number of kits the firm has in their possession. Customers were instructed to provide recall notification to other firm's who received the recalled kits from their direct account. For any questions regarding this recall call 631-924-4000, ext 142.

Device

Device Recall CENTURION V.A.D. TRAY
  • 모델명 / 제조번호(시리얼번호)
    BATCHES 2009102950, 2009121550, 2010012250, 2010021550, 2010033050, 2010042850, 2010060850, 2010061050, 2010082650 AND 2010090850.                          .
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Material HT1995A, V.A.D.TRAY, CENTURION V.A.D. TRAY, REORDER HT1995A, STERILE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.4058 www.centurionmp.com || FACILITATES LINE INSERTION
  • Manufacturer
    Centurion Medical Products Corporation

Manufacturer

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