Device Recall ISOMED refill kit

  • 모델명 / 제조번호(시리얼번호)
    Lot 60538731, Use by Date is May 10, 2009.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide -- including the U.S. (AK, AL, AR, AZ, CA, CT, DC,DE, FL, GA, HI, ID, IL, IN, KY, LA, MA, MI, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, and WV) and Argentina, Australia, and Hong Kong.
  • 제품 설명
    IsoMed Refill Kit, Model 8553, Lot Number 60538731, is intended for use in refilling Medtronic IsoMed pumps. Contents: Two 22-gauge needles, extension tubing set with y-connector and clamp, Filter, 10-ml syringe, 60-ml lidded syringe, Fenestrated drape, Template; Use by Date May 10, 2009; Medtronic, Inc., Minneapolis, MN. Product is packaged in a sterile container.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Medtronic Neuromodulation, 800 53rd Ave NE, PO Box 1250, Minneapolis MN 55440-1250
  • Source
    USFDA