Device Recall Optionvm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 C.R. Bard, Inc. 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
    74712
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2831-2016
  • 사례 시작날짜
    2016-07-11
  • 사례 출판 날짜
    2016-09-15
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-03-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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, retention type, balloon - Product Code EZL
  • 원인
    During an fda inspection it was found out that the practical foley catheters to be potentially nonsterile.
  • 조치
    C.R. Bard sent an Urgent - Medical Device Product Recall letter dated July 8, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm notifies customers of the recall, provides a clinical risk statement, and gives instructions regarding product disposition. Facilities are instructed to examine their inventory and quarantine any recalled product. The firm requested that customers complete the Recall & Effectiveness Check Form if product is or is not in inventory. If product was further distributed, customers should be forwarded the recall notification letter and Recall& Effectiveness Check Form. If you or the patient using these catheters has had an adverse event related to the recalled catheters, please contact Bard Medical Division Field Assurance at 1-800-526-4455 (option 5, then option 4) or via email at BMD.FieldAssurance@crbard. com.

Device

  • 모델명 / 제조번호(시리얼번호)
    Device Listing No.: D022515. CatalogNo.: MV39016. Lot No.: P1007642, P1007465, P1007466, P1007643, P1007641, P1007640, P1007468, P1007467. Exp Date: 08/01/2016.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to the states of : AL, CA, CO, FL, IL, IN, MA, MD, NJ, NY, OR, PA, TN, WA, and WI.
  • 제품 설명
    Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only.
  • Manufacturer

Manufacturer