Device Recall VCare, Standard/Small/Large Cervical Cup

  • 모델명 / 제조번호(시리얼번호)
    VCare¿ Standard Cervical Cup (Catalog # 60-6085-100), VCare¿ Small Cervical Cup (Catalog # 60-6085-101) and VCare¿ Large Cervical Cup (Catalog # 60-6085-102). Lot codes for product manufactured between 01/20/2009 (Lot 090120X) and through 07/31/2009 (Lot 090731X). Lot Code Key = YYMMDDX, where X = manufacturing shift (e.g. 1, 2 or 3)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including NY, TX, CA, IA, AZ, PA, IN, and KS and the countries of Austria, Jordan, Turkey, China, Portugal, Chile, Belgium, Ecuador, Brazil, Romania, Japan, Malaysia, India Switzerland, Colombia, Netherlands, Spain, Saudi Arabia, France, and Canada.
  • 제품 설명
    VCare¿ Vaginal-Cervical Ahluwalia's Retractor-Elevator devices. The VCare IFU is packaged one per carton of eight VCare Pouched Devices. The Instructions for Use is an 8.5" x 12" 12-page booklet and is packed loose in the carton. Only the carton will have to be opened to replace the old IFU; there is no need to open the sterile packaging of the individual VCare pouches. || The ConMed VCARE¿ Retractor/Elevator is indicated for manipulation of the uterus and injection of fluids or gases during laparoscopic procedures such as Laparoscopic Assisted Vaginal Hysterectomy (LAVH), Total Laparoscopic Hysterectomy (TLH), minilap, laparoscopic tubal occlusion, or diagnostic laparoscopy and also maintains pneumoperitoneum by sealing the vagina once colpotomy is performed.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    ConMed Corporation, 525 French Road, Utica NY 13502
  • 제조사 모회사 (2017)
  • Source
    USFDA