Food, drugs, devices › Gambro Renal Products, Incorporated
Device recall: Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set
FDA enforcement event 67797 is a device recall by Gambro Renal Products, Incorporated of Lakewood, CO, initiated 9 Dec 2013 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 22 Dec 2015. Initiation: voluntary: firm initiated. Gambro Renal Products, Incorporated has 3 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Gambro Renal Products, Incorporated, Lakewood, CO.
Reason for recall
"Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets."
Distribution
"Worldwide Distribution-USA (nationwide) and the countries of Canada, Mexico, and Colombia."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1455-2014 | 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… | 306,525 sets (20435 boxes of 15 sets) | Class II | Terminated | 23 Apr 2014 |
Context
Other enforcement events for Gambro Renal Products, Incorporated
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 18 Jul 2014 | Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches per carton box | Device | Class II | 15 |
| 16 Apr 2014 | Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of a | Device | Class II | 2 |
All 3 events for Gambro Renal Products, Incorporated
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution-USA (nationwide) and the countries of Canada, Mexico, and Colombia."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 22 Dec 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.