Device Recall Gambro

  • Model / Serial
    Prisma M60 POSTDILUTION set. Product number 104183. Batch number 13C2103. Expiry 03/2015.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic pouch, 4 pouches per carton box
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Gambro Renal Products, Incorporated, 14143 Denver West Pkwy, Lakewood CO 80401-3266
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

16 devices with a similar name

Learn more about the data here

  • Model / Serial
    Serial numbers: PA0101 thru PA0681, PA1001 thru PA1774.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution -- including states of AL, CA, FL, GA, IN, MD, ME, MI, MS, NC, NH, NY, OH, PA, SC, TX, VA, and WI.
  • Product Description
    Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Gambro Lundia AB, Sweden.
  • Manufacturer
  • Model / Serial
    Prisma HF1000 preset (new design). Product number 107639. Batch number 12A1303 to 13E3104. Expiry 01/2014 to 05/2015
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in a plastic pouch, 4 pouches per carton box
  • Manufacturer
  • Model / Serial
    Lot number: 1000039228, 1000048340, 1000050644, 1000050648, 1000054032, 1000058516, 1000064913, 1000065817, 1000065823, 1000066430, 1000063347, 1000067984, 1000068071, 1000071417, 1000071430, 1000073434, 1000073436, 1000073438, 1000074660, 1000074661, 1000074662, 1000075553
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Canada, Mexico, and Colombia.
  • Product Description
    Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set, STND PRM LN and 103401 (003414500) - Cartridge set, PRM_LN_INJ_PT. The Gambro Cartridge Sets are single use sterile tubing sets intended to provide extracorporeal blood transport circuit for hemodialysis treatments for Gambro Phoenix and COBE Centrisystem 3 (and 3+) Dialysis Delivery Systems.
  • Manufacturer
  • Model / Serial
    Product Number 1071441. Batch number 12A1905 to 14C1706. Expiry date 01/2015 to 03/2017.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches per carton box
  • Manufacturer
  • Model / Serial
    Prisma TPE 2000 set. Product number 109672. Batch number 12B0607. Expiry 02/2015.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic pouch, 4 pouches per carton box
  • Manufacturer
11 more