Devices

Device Recall Cartridge Blood Set

  • Model / Serial
    Serial numbers: 04P158215 and below, 03P158XXX (all lots)
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution --- including states of CA,GA, IL, KY, MO, NJ, NM, NY, NC, ND, PA, TN, and VA.
  • Product Description
    Gambro Cartridge Blood Set, 003410-510, is intended for single use in a hemodialysis treatment using the Phoenix and Centry system 3 Dialysis Delivery Systems.
  • Manufacturer
    Gambro Renal Products, Inc.
  • 1 Event

Manufacturer

Gambro Renal Products, Inc.
  • Manufacturer Address
    Gambro Renal Products, Inc., 14143 Denver West Pkwy, Lakewood CO 80401-3116
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall Cartridge Blood Set
  • Model / Serial
    Serial numbers: 0XP15XXXX (all lots)
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution --- including states of CA,GA, IL, KY, MO, NJ, NM, NY, NC, ND, PA, TN, and VA.
  • Product Description
    Gambro Cartridge Blood Set, 0141080XXXC, is intended for single use in a hemodialysis treatment using the Phoenix and Centry system 3 Dialysis Delivery Systems.
  • Manufacturer
    Gambro Renal Products, Inc.