Events

Langston Dual Lumen Catheters 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Vascular Solutions, 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
    56709
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2608-2010
  • 사례 시작날짜
    2010-09-02
  • 사례 출판 날짜
    2010-09-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-04-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94333
  • 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, diagnostic - Product Code DQO
  • 원인
    Investigation of a recent device experience report has made us aware of a potential problem with our 6f langston dual lumen pigtail catheter (model 5540) with the following lot numbers: 548110, 548227, 548364, 548430, 548554 & 548723. recently, it was reported that pouches containing langston pigtail catheter (model 5540) were missing a seal, posing a risk of product contamination. it is possib.
  • 조치
    Consignees were sent on 9/2/10, a Vascular Solutions "Urgent Medical Device Field Action" letter dated September 1, 2010. The letter was addressed to Cath Lab Manager. The letter descried the product and the problem. Provided instructions to examine pouches of opened boxes to see if they have not been sealed. If unsealed, they recommended to remove pouches from the current inventory. For unopened boxes they recommended to remove the boxes from the inventory. Requested consignees to complete the Field Action Customer Inventory Form included with the letter. For any questions, please contact the firm at 763-656-6032.

Device

Langston Dual Lumen Catheters
  • 모델명 / 제조번호(시리얼번호)
    Lot 548110, 548227, 548364, 548430, 548554, and 548723.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS,MO, NE, NY,NH, NJ, NM, NY,NC, OH, OK, OR, A, PR, SC, TN, TX, UT, VA, WA, WV, WI, and WY. SINGAPORE, MEXICO, CANADA, SPAIN, AUSTRIA, GERMANY, ITALY, ENGLAND, and SWITZERLAND.
  • 제품 설명
    Langston Dual Lumen Catheters, 6F, REF 5540, Sterile EO, RX only, Vascular Solutions, Inc, 6464 Sycamore Court, Minneapolis, MN 55369, 110 cm length, || Usage: Indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites, This type of pressure measurement is useful in determining transvalvular, intravascular and interventricular pressure gradients.
  • Manufacturer
    Vascular Solutions, Inc.

Manufacturer

Vascular Solutions, Inc.
  • 제조사 주소
    Vascular Solutions, Inc., 6464 Sycamore Ct, Maple Grove MN 55369-6032
  • 제조사 모회사 (2017)
    Teleflex Incorporated
  • Source
    USFDA