Device Recall Diametrics Medical IRMA

  • 모델명 / 제조번호(시리얼번호)
    The lot on the boxes of the product is ALHCB (this is the correct lot) and is incorrectly printed as ALOHC on the packages of the recalled disposable cartridges.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    The product was shipped to 13 hospitals in California, Colorado, Florida, Iowa, Kansas, Minnesota, New Hamshire, Texas, and Wisconsin.
  • 제품 설명
    IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+, K+, iCa Cartridge, Part Number 039903(M3586A). There are 25 disposable cartridges in a box of IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+, K+, iCa Cartridges, Part Number 039903(M3586A).
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Diametrics Medical, Inc., 2658 Patton Road, Roseville MN 55113
  • Source
    USFDA