Device Recall 115 V Blanketrol II, Model 222S HyperHypothermia System

  • Modèle / numéro de série
    Model Number 222S; Serial #s: 133-2-00697, 133-2-00698; 133-2-00699; 133-2-00700; 133-2-00701; 133-2-00702; and 133-2-00703:.Part # 86165
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The product was distributed to one customer in MI, and internationally (Taiwan)
  • Description du dispositif
    115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part number 86165.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Cincinnati Sub-Zero Products Inc, 12011 Mosteller Rd, Cincinnati OH 45241-1528
  • Société-mère du fabricant (2017)
  • Source
    USFDA