Device Recall AxoTrack I Sterile Procedure Kit, 18G (K100118XTW)

  • 모델명 / 제조번호(시리얼번호)
    Product Ref#70956, Lot #62191-000, Expiration Date: 2/28/2014,  Lot #62193-000, Expiration Date: 2/28/2014, Lot #62360-000, Expiration Date: 2/28/2014, Lot #62922-000, Expiration Date: 4/30/2014, Lot #63191-000 and Expiration Date: 10/31/2014 (24/case labeled for US); Product Ref#70957, Lot # 62188-000, Expiration Date: 2/28/2014, Lot # 62435-000, Expiration Date: 2/28/2014, Lot # 62489-000 Expiration Date: 3/31/2014 and Lot # 63191-000, Expiration Date: 10/31/2014 (5/case labeled for US); Product Ref#71489, Lot # 63191-000, Expiration Date: 10/31/2014 (24/case labeled for EU) and Product Ref#71489, Lot # 62489-000, Expiration Date: 3/31/2014, Lot # 62529-000, Expiration Date: 3/31/2014 and Lot # 63191-000 Expiration Date: 10/31/2014 (5/case labeled for EU).
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CT, FL, GA, IN, KY, LA, MA, MI, MO, NC, NJ, NY OH, OR, PA, SC, TN, TX, VA, and WA and the countries of Belgium, Hong Kong, India, Japan, Panama and Singapore.
  • 제품 설명
    AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5/case labeled for US, 24/case labeled for EU, 5/case labeled for EU). || Sterile Procedure Kit for use AxoTrack enabled Ultrasound Transducer for magnetic needle tracking.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Soma Access Systems LLC, 109 Laurens Rd Ste 4c, Greenville SC 29607-1860
  • 제조사 모회사 (2017)
  • Source
    USFDA