Recall Z-1455-2014— Gambro Renal Products, Incorporated
Class II · Terminated
Class II FDA medical device recall by Gambro Renal Products, Incorporated, initiated 2013-12-09, terminated 2015-12-22. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets..
- Recalling firm
- Gambro Renal Products, Incorporated
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-12-09
- Terminated
- 2015-12-22
- Firm location
- Lakewood, CO, United States
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.
Reason for recall
Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets.
Data sourced from openFDA. This site is unofficial and independent of the FDA.