Events

Centurion Sterile 84 Rubber Bands 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
    66830
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0464-2014
  • 사례 시작날짜
    2013-10-28
  • 사례 출판 날짜
    2013-12-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-01-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123693
  • 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
    Device, general medical - Product Code LDQ
  • 원인
    Package labeling indicates both "latex free" and "contains natural rubber latex" . the rubber bands do contain natural rubber latex. this could cause a significant risk to users with latex allergies.
  • 조치
    Centurion sent a Urgent Recall Notification letter via Certified Mail October 31, 2013, return receipt to all affected customers. The affected Centurion Medical Products Corporation sales representatives were notified via email on October 28, 2013. Customers were instructed to destroy all implicated product and complete the accountability record included with the notice and fax to 517-546-3356. Customers were asked to forward a copy of the notice if product was further distributed. Additional notices will be mailed to non-responsive customers via Certified Mail Return Receipt, and will be documented in the recall file. For further questions please call (517) 546-5400.

Device

Centurion Sterile 84 Rubber Bands
  • 모델명 / 제조번호(시리얼번호)
    EB84, Lot 2013041801 Expriation 2018/03
  • 유통
    US Distribution including the states of GA, LA and NY.
  • 제품 설명
    Centurion Sterile # 84 Rubber Bands Reorder EB84, Caution: This product contains natural rubber latex which may cause allergic reactions. || LATEX FREE , CAUTION: FEDERAL lAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN || Single Use Only || bands items together and podiatry office uses bands as tourniquet on toe during in grown toenail procedure
  • Manufacturer
    Centurion Medical Products Corporation

Manufacturer

Centurion Medical Products Corporation
  • 제조사 주소
    Centurion Medical Products Corporation, 301 Catrell Dr, Howell MI 48843-1703
  • 제조사 모회사 (2017)
    Medline Industries Inc.
  • Source
    USFDA