Gambro Cartridge Blood Set — Class II medical device recall Z-1455-2014
Terminated recall by Gambro Renal Products, Incorporated, reported 2014-04-23, distributed nationwide. Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets.
| Recall number | Z-1455-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gambro Renal Products, Incorporated, Lakewood, CO, United States |
| Recall initiated | 2013-12-09 |
| Classified | 2014-04-11 |
| Reported by FDA | 2014-04-23 |
| Terminated | 2015-12-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CO, MX |
| Lot numbers | 1000039228, 1000048340, 1000050644, 1000050648, 1000054032, 1000058516, 1000063347, 1000064913, 1000065817, 1000065823, 1000066430, 1000067984, 1000068071, 1000071417, 1000071430, 1000073434, 1000073436, 1000073438, 1000074660, 1000074661, 1000074662, 1000075553 |
| Model numbers | 101025 |
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 for recall
Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1455-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.