Device Recall PDS II (polydioxanone) Suture

  • 모델명 / 제조번호(시리얼번호)
    Lot # Expiration Date APM091 2013-07-31 12:00AM APM861 2013-07-31 12:00AM APZ105 2013-07-31 12:00AM AMK590 2013-07-31 12:00AM APZ721 2013-07-31 12:00AM APZ098 2013-07-31 12:00AM APZ283 2013-07-31 12:00AM APM692 2013-07-31 12:00AM APM753 2013-07-31 12:00AM AP6005 2013-07-31 12:00AM APM748 2013-07-31 12:00AM APZ367 2013-07-31 12:00AM APM298 2013-07-31 12:00AM APZ245 2013-07-31 12:00AM AP6053 APZ644 2013-07-31 12:00AM APM524 2013-07-31 12:00AM APZ908 2013-07-31 12:00AM AP6061 2013-07-31 12:00AM APM635 2013-07-31 12:00AM APZ126 2013-07-31 12:00AM APZ298 2013-07-31 12:00AM APZ153 2013-07-31 12:00AM APZ381 2013-07-31 12:00AM AP2315 2013-07-31 12:00AM AP2333 2013-07-31 12:00AM AP2331 2013-07-31 12:00AM AP2332 2013-07-31 12:00AM AP2241 2013-07-31 12:00AM AP2355 2013-07-31 12:00AM APM221 2013-07-31 12:00AM APM844 2013-07-31 12:00AM
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- USA, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Greece, Hong Kong, Israel, Japan, Korea, Luxemburg, Mexico, New Zealand, Norway, Panama, Puerto Rico, Sweden, Taiwan, United Kingdom, Uruguay, and Venezuela.
  • 제품 설명
    PDS II (polydioxanone) Suture, Ethicon, Inc., A Johnson & Johnson Company, Somerville, NJ. || Sutures are intended for general soft tissue approximation and/or ligation.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Ethicon, Inc., US Highway 22 West, Somerville NJ 08876
  • 제조사 모회사 (2017)
  • Source
    USFDA