Events

Device Recall TwinPass Dual Access Catheter 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
    52633
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1712-2009
  • 사례 시작날짜
    2009-07-02
  • 사례 출판 날짜
    2009-08-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-04-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83496
  • 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, percutaneous - Product Code DQY
  • 원인
    Three occurrences of twin-pass¿ catheters containing a piece of ptfe beading material in the otw lumen have been reported to vascular solutions. the ptfe beading material is a processing aide used during hydrophilic coating. the beading is to be removed followed by a visual inspection prior to packaging.
  • 조치
    Vascular Solutions, Inc. issued an "Urgent: Medical Device Recall - Lot Specific" notice dated July 6, 2009. The letter described the problem and product involved and asked Consignees to immediately check their Twin-Pass¿ catheter inventory, remove any affected units and complete the Product Recall Inventory Form and return to Customer Service Department. For further questions, contact Vascular Solutions, Inc. at 1-763-656-4300.

Device

Device Recall TwinPass Dual Access Catheter
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers:  540787, 540909, 541079, 541304, 541342, 541881, 541992, 542111, 542253, 542302, 542693, 542875, 542962, 542994, 543173, 543304, 543508, 543590, 543591, 543698, 543775, 543922, 544188, 544315, 544597 and 544831.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- Including Puerto Rico and states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and DC and countries of CANADA, SPAIN, GREECE, IRELAND, NORWAY, SWITZERLAND, ENGLAND, TURKEY, ISRAEL, GERMANY, AUSTRIA, TAIWAN, FINLAND, SWEDEN, FRANCE, IRELAND and PORTUGAL.
  • 제품 설명
    Twin-Pass¿ Dual Access Catheter , REF 5200, sterilized with Ethylene Oxide, RX Only, Non-Pyrogenic, Manufactured by Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369. || The TWIN-PASS catheters are intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents.
  • Manufacturer
    Vascular Solutions, Inc.

Manufacturer

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