Device Recall Autopen Classic

  • 모델명 / 제조번호(시리얼번호)
    Lot 7JH, UPC Code 384703800014
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including FL, IL, NV, NJ, OH, and TN.
  • 제품 설명
    Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, || The product is a non-sterile automatic subcutaneous injection device which delivers insulin.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Owen Mumford USA, Inc., 1755 W Oak Commons Ct, Marietta GA 30062-2280
  • 제조사 모회사 (2017)
  • Source
    USFDA