Device Recall St Jude Medica CPS Direct SL

  • 모델명 / 제조번호(시리얼번호)
    Models: CPS Direct SL (Models 410110; 410111; 410112; 410113; 410114; 410115; 410116; 410120; 410121; 410122; 410123; 410124; 410126).  CODE INFORMATION: All devices with sterile lot numbers beginning with S, CR, or any C4 lot numbers starting with CP 05274 or higher.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide-including states of AZ, CA DC, FL GA, IN, KS, LA, MA, MD, ME, MI, MN, MS, NC, NH, NY, OH, PA, RI, TN, VA, and WI and countries of Austria, Belgium, Denmark, Finland, Netherlands, Sweden, France, Germany, Italy, UK, Spain, Portugal, Poland, Switzerland, Australia, New Zealand, Thailand, Hong Kong, Korea, Malaysia and Singapore.
  • 제품 설명
    St. Jude Medical-CPS Direct SL- slittable CRT lead delivery tool. -Model Numbers 410110, 410111, 410112, 410113, 410114, 410115, 410116, 410120,410121. 410122, 410123, 410124, 410125 and 410126.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    St Jude Medical CRMD, 15900 Valley View Ct, Sylmar CA 91342-3577
  • Source
    USFDA