Device Recall SPS1, Static Preservation Solution (UW Solution)

  • Model / Serial
    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
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Organ Recovery Systems, Inc., 1 Pierce Pl Ste 475, Itasca IL 60143-1253
  • Manufacturer Parent Company (2017)
  • Source
    USFDA