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Gambro Renal Products, Incorporated recalls Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set
Recalled April 23, 2014 · FDA recall Z-1455-2014 · Gambro Renal Products, Incorporated
Hazard
Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets. · FDA Class II
Units
306,525 sets (20435 boxes of 15 sets)
Sold at
Worldwide Distribution-USA (nationwide) and the countries of Canada, Mexico, and Colombia.
Description
Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets.
Product
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(s)
Gambro Renal Products, Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →