Device Recall Belzer UW & Waters IGL Cold Storage Solution

  • Modèle / numéro de série
    UDI 00810805000163, and UDI 00810805000071.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA and Europe.
  • Description du dispositif
    Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog No. CSS/2000/US; and, Belzer UW Cold Storage Solution, Catalog No. BUW_002. || Intended for the hypothermic flushing and storage of specific organs in preparation for storage, transportation, and transplantation into a recipient.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Preservation Solutions, Inc., 1099 Proctor Dr, Elkhorn WI 53121-2027
  • Source
    USFDA