Events

Device Recall OUTPATIENT Port Access Dressing 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
    57767
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1468-2011
  • 사례 시작날짜
    2011-01-14
  • 사례 출판 날짜
    2011-03-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-06-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97371
  • 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, wound dressing - Product Code MCY
  • 원인
    The firm is conducting a subrecall of kits containing triad groups alcohol prep pads. triad initiated a recall of prep pads due to a concern about potential contamination of the products with an objectional orgainism, bacillus cereus.
  • 조치
    The firm, Centurion Medical Products, sent an "URGENT PRODUCT RECALL NOTICE" dated January 12, 2011 to affected customers via Certified Mail, Return Receipt Requested. The notice described the product, problem and action to be taken. The customers were instructed to identify and remove all inventory of the recalled kits in their possession; forward a copy of this notice to any customers that this product was further distributed to, and complete and return the attached Accountability Record form via fax to 517-546-3356 or email to: lcarpenter@centurionmp.com. The notice states that a Centurion representative will contact them regarding retrieval of the product from the facility. Should your require additional information, please contact the Director of Quality Assurance & Regulatory Affairs at (517) 546-5400 ext. 1135.

Device

Device Recall OUTPATIENT Port Access Dressing Tray
  • 모델명 / 제조번호(시리얼번호)
    2010111050, 2010100570, 2010122250, 2010120250, 2010051450, 2010061650, 2010071550, 2010030850, 2010080550, 2010060350, 2010090950, 2010042850.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: USA including state of: CT, ID, NM, MA, MO, MT, VA and SC.
  • 제품 설명
    OUT-PATIENT Port Access Dressing Tray, DT14875, Sterile, Centurion Medical Products Corp., Williamston, MI. || These kits are used for dressing changes.
  • 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