Devices

Device Recall Bardex Lubricath

  • 모델명 / 제조번호(시리얼번호)
    Catalog Number 6016L22 (all units packaged from January 1999 and shipped prior to September 2002).
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The product was distributed nationwide, Canada, Belgium and Germany.
  • 제품 설명
    Bardex¿ Foley Catheter, 22 Fr 40cc- 20cc Ribbed Balloons, Coleman Model Red Latex, 3 Way Radiopaque, Lubricath Coated, Sterile, Single Use Device, C.R. Bard, Inc., Covington, GA 30014. The catheter is an open whistle tip with two eyes on the same side. It is made of red latex for added catheter stiffness and radiopacity, with a Lubricath hydrophilic coating. This product has 3 lumens; a lumen for drainage, a lumen for inflation of the bladder balloon, and a lumen for inflation of the prostatic balloon.
  • Manufacturer
    C.R. Bard, Inc., Urological Division
  • 1 Event

제조사

C.R. Bard, Inc., Urological Division
  • 제조사 주소
    C.R. Bard, Inc., Urological Division, 8195 Industrial Blvd NE, Covington GA 30014
  • Source
    USFDA

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Device Recall Bardex Lubricath 3Way 75cc Continuous Irrigation Foley Catheter
  • 모델명 / 제조번호(시리얼번호)
    Catalog # 01267522 Lot #'s: NGBR0383 and NGBR2129
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 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
    C.R. Bard, Inc.