Device Recall Bardex Lubricath 3Way 75cc Continuous Irrigation Foley Catheter 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
    80150
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2064-2018
  • 사례 시작날짜
    2017-12-13
  • 사례 상황
    Open, Classified
  • 사례 국가
  • 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, coude - Product Code EZC
  • 원인
    Foley catheter with incorrect retainer cap print.
  • 조치
    On December 13, 2017 a letter was sent to all their customers informing them of the following: Bard Medical Division (BMD), C.R Bard, Inc., would like to inform you of a potential labeling issue involving the BARD product code and lot numbers listed below. Manufacturing of these affected products began May 2017.Due to a manufacturing issue, there is a potential for catheters with the two lot numbers listed above to have the incorrect information printed on the purple retainer cap. The incorrect print specifies that the balloon should be inflated with 10mL of water. However, the correct volume to use to inflate the catheter balloon is 75cc . If the user underinflates the balloon with only 10mL of water, the expected effect of helping stop the bleeding as an adjunct to conventional hemostasis post-TURP may not happen as quickly as desired, likely leading to a marginal severity of harm. Additionally, the catheter may become dislodged from the patient. Instructions to Customer: "Examine your inventory and identify any product subject to this communication. During use, adhereto the correct inflation volume as stated in the packaging. "Product return is not required. If a unit does not meet your needs or you have any questions,please contact our customer service at 1-800-526-4455. "If you have further distributed or transferred this product, please identify the respective organizationsand notify them at once of this product communication. Your notification to these organizations maybe enhanced by including a copy of this medical device communication letter. We appreciate your cooperation and assistance in dealing with this matter and sincerely apologize for any inconvenience that may result from this action. If you have any questions please do not hesitate to contact your Bard representative.

Device

  • 모델명 / 제조번호(시리얼번호)
    Catalog # 01267522 Lot #'s: NGBR0383 and NGBR2129
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    FL, NY, MN and TX Canada, Japan and Taiwan
  • 제품 설명
    Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522)
  • Manufacturer

Manufacturer