Device Recall Ambu AuraGain Single Use Laryngeal Mask Sterile

  • Modèle / numéro de série
    Catalog Number:408300000  Size #3:All lots from 1632796 through lot number 1808911except lot number 1779966,1782239, 1795914   Catalog Number: 408400000 Size #4 All lots from 1632799 through lot number 1790075.   Catalog Number:408500000 Size #5 All lots from 1632802 through lot number 1810863.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Please see attached consignee list
  • Description du dispositif
    Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile || for use as an alternative to a face mask for achieving and maintaining control of the airway during routine emergency anesthetic procedures.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Ambu Inc., 6230 Old Dobbin Ln Ste 250, Columbia MD 21045-5955
  • Société-mère du fabricant (2017)
  • Source
    USFDA