Events

Device Recall HydroSil Hydrophilic 12 French Male Length Sample Packs 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Rochester Medical Corp 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
    51205
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1084-2009
  • 사례 시작날짜
    2009-01-14
  • 사례 출판 날짜
    2009-03-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-04-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79221
  • 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
    Urological Catheter - Product Code KOD
  • 원인
    Rochester medical observed some magic3 and hydrosil(r) catheter packages in which the catheter was caught in the package seal during the packaging process.
  • 조치
    Consignees were contacted by telephone or in-person visit. The communication provided the reason for the recall and a list of affected products and their lot numbers, and instruction for the removal. Distributors were given instructions to notify their customers in turn. For the customers that were not reached via telephone call or in-person, a letter, "Voluntary recall of magic product samples," was used for the recipients of product samples and sent via e-mail. The letter was dated January 14, 2009 and asked customers to destroy all of their remaining sample inventory of the affected lot numbers.

Device

Device Recall HydroSil Hydrophilic 12 French Male Length Sample Packs
  • 모델명 / 제조번호(시리얼번호)
    Lot #53607048
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA including states of CA, FL, GA, ID, IL, LA, MD, MA, MI, MN, NJ, NM, NY, OH, PA, and WA and countries of United Kingdom.
  • 제품 설명
    HydroSil (Intermittent Urethral Catheter), Hydrophilic 12 French Male Length Sample Packs REF#63612SPL || Rochester Medical, Distributed by Rochester Medical Ltd 10 Commerce Way, Lancing West Sussex BN158TA, Sterile R, Rochester and HydroSil are registered trademarks of Rochester Medical Corporation. Rochester Medical Corporation, Stewartville, MN 55976. || Intended for use for bladder management including urine drainage, collection and measurement.
  • Manufacturer
    Rochester Medical Corp

Manufacturer

Rochester Medical Corp
  • 제조사 주소
    Rochester Medical Corp, 1 Rochester Medical Dr Nw, Stewartville MN 55976-1647
  • Source
    USFDA