Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Gambro Cartridge Blood Set Recalled by Gambro Renal Products, Incorporated Due to Occluded heparin tubing events preventing anticoagulation dosing on...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Gambro Renal Products, Incorporated directly.
Affected 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.
Quantity: 306,525 sets (20435 boxes of 15 sets)
Why Was This Recalled?
Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Gambro Renal Products, Incorporated
Gambro Renal Products, Incorporated has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report