Device Recall Cyto Jar Fixative

  • Modèle / numéro de série
    item #3801825, reorder #01825, lot #073013
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: USA including states of: Michigan, Missouri and New York.
  • Description du dispositif
    Surgipath Cyto Jar Fixative; a 120 mL clear, leakproof container prefilled with 45 mL of preservative containing polyethylene glycol for the convenient collection, fixation and preservation of all cytologic specimens, 50 jars per case; for in vitro diagnostic use only; Leica Biosystems, 5205 Rt. 12, Richmond, IL 60071; Made in USA || The Cyto Jar is for the convenient collection, fixation and preservation of all cytologic specimens. The 120 mL clear, leakproof container is prefilled with 45 mL of preservative containing polyethylene glycol. It can be used for rinsing aspiration needles or bronchial brushes and for the direct collection of sputum specimens.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Leica Biosystems Richmond Inc., 5205 Route 12, Richmond IL 60071
  • Société-mère du fabricant (2017)
  • Source
    USFDA