Devices

Device Recall OPEN HEART PACK

  • Modèle / numéro de série
    Code:9002618 Lots: 140915325 exp. 10/31/15 141015615 exp. 11/30/15 141216324 exp. 12/31/15 150418448 exp. 5/31/16 150116558 exp. 5/31/16 150116558 exp. 5/31/16 150418449 exp. 5/31/16
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Distributed Only in Puerto Rico.
  • Description du dispositif
    OPEN HEART PACK 1/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
  • Manufacturer
    Customed, Inc
  • 1 Event

Fabricant

Customed, Inc
  • Adresse du fabricant
    Customed, Inc, Calle Igualdad Final #7, Fajardo PR 00738
  • Société-mère du fabricant (2017)
    Customed Inc
  • Source
    USFDA