FDA-Device2014-04-23Class II
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.
Gambro Renal Products, Incorporated
Hazard
Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets.
Sold states
Worldwide Distribution-USA (nationwide) and the countries of Canada, Mexico, and Colombia.
Affected count
306,525 sets (20435 boxes of 15 sets)
Manufactured in
14143 Denver West Pkwy, N/A, Lakewood, CO, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1455-2014Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief