Events

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
    75536
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0647-2017
  • 사례 시작날짜
    2016-10-21
  • 사례 출판 날짜
    2016-12-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-07-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150739
  • 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
    Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
  • 원인
    The kits contain multi-med single lumen catheters that have a potential for excess material to remain at the tip of the catheter from the manufacturing process. it is possible that the excess material may separate from the catheter during use and pose a potential risk of embolism, which could result in serious injury or death.
  • 조치
    Centurion sent an Urgent Recall Notice dated October 21, 2016, 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 this product immediately, and forward a copy of this notice to other users to whom this product may have been further distributed. In addition, customers were instructed to complete the attached form at their earliest convenience and fax to 517-546-3356. For questions regarding this recall call 517-546-5400.

Device

Centurion
  • 모델명 / 제조번호(시리얼번호)
    Centurion Kit Code  ECVC1680  Kit Description SINGLE LUMEN INSERTION BUNDLE Lot Number(s) 2016062150 2016062950 2016070650 Centurion Kit Code ECVC4785  Kit Description SINGLE LUMEN BUNDLE Lot Number(s) 2016081550 Centurion Kit Code M11620HKIC  Kit Description MULTI-MED - Central Venous Catheter (1 Lumen, 16G, 20cm)  Lot numbers 2016051050  2016053150 2016060750 2016061550 2016063050 2016072050 2016080250 2016091950 Centurion Kit Code M11620HKICNL Kit Description  MULTI-MED - Central Venous Catheter (1 Lumen, 16G, 20cm)  Lot numbers 2016060750 2016072650 2016093050 2016101050 Centurion Kit Code M11620HS  Kit Description MULTI-MED - Central Venous Catheter (1 Lumen, 16G, 20cm)  Lot numbers 2016052050 2016062850 2016082350 2016082650 2016090250 Centurion Kit Code M11620KC  Kit Description MULTI-MED - Central Venous Catheter (1 Lumen, 16G, 20cm)  Lot numbers 2016050950 2016053150 2016060750 2016071250 2016080350 2016082950 Centurion Kit Code M11620KCNL  Kit Description MULTI-MED - Central Venous Catheter (1 Lumen, 16G, 20cm)  Lot numbers  2016060850 2016061650 2016062050 2016070550 2016071950 2016080250 2016090750 Centurion Kit Code M12013K  Kit Description MULTI-MED - Central Venous Catheter (1 Lumen, 20G, 13cm)  Lot numbers  2016071350 2016072050 2016092650 2016100650 Centurion Kit Code M12013KNL  Kit Description MULTI-MED - Central Venous Catheter (1 Lumen, 20G, 13cm)  Lot numbers  2016072950 2016082450
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Multi-Med Single Lumen Catheters sold in Centurion convenience kits. || The Multi-Med catheter is indicated for use in patients requiring administration of solutions, blood sampling, and central venous pressure monitoring.
  • 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