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
  • 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
  • 1 Event

제조사

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