Device Recall RENASYSGauze with Soft Port Kit

  • 모델명 / 제조번호(시리얼번호)
    ALL LOT #'s: 2013020417 and lower - Small, 2013020209 and lower- Medium, 2013020382 and lower - Large, and 2013020501 and lower- X-Large
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, KY, LA, MA, MS, MT, NC, NJ, NV, NY, OH, OR, PA, TN, TX, VA, WA, WI, WV, HI and the countries Dubai, Curacao, Argentina, Australia, Chile, Germany, France, England, Hong Kong, Kuwait, Lebanon, Libya, Sri Lanka, Malaysia, New Zealand, Manila, Saudi Arabia, South Africa, Singapore, Turkey, Taipei and Vietnam.
  • 제품 설명
    Smith & Nephew RENASYS-Gauze with Soft Port Kit REF #'s: 66800933, 66800934, 66800935, and 66800936 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Smith & Nephew Inc., 970 Lake Carillon Dr, Ste 110, Saint Petersburg FL 33716-1130
  • 제조사 모회사 (2017)
  • Source
    USFDA