Device Recall SPS1, Static Preservation Solution (UW Solution)

  • Modèle / numéro de série
    Batch / Lot Number: PBR-0060-392, Reference Number: SPS1_1 LITER, Manufacturer Date: 06/22/2016, Expiration Date: 06/22/2018 ;   Batch / Lot Number: PBR-0074-330, Reference Number: SPS1_2 LITER, Manufacturer Date: 07/13/2016, Expiration Date: 07/13/2018  Batch / Lot Number: PBR-0074-337  Batch / Lot Number: PBR-0060-386
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide
  • Description du dispositif
    SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Organ Recovery Systems, Inc., 1 Pierce Pl Ste 475, Itasca IL 60143-1253
  • Société-mère du fabricant (2017)
  • Source
    USFDA