FDA Device recall Z-1455-2014
Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set, STND PRM LN and 1…
- FDA Device
- Class II
- terminated
- Published 2014-04-23
On 2014-04-23 the FDA classified a Class II recall of Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set, STND PRM LN and 1… by Gambro Renal Products, citing occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1455-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-12-09 |
| Published | 2014-04-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Gambro Renal Products |
| Distribution | US |
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.
Identifiers
| code_info | Lot number: 1000039228, 1000048340, 1000050644, 1000050648, 1000054032, 1000058516, 1000064913, 1000065817, 1000065823,…Lot number: 1000039228, 1000048340, 1000050644, 1000050648, 1000054032, 1000058516, 1000064913, 1000065817, 1000065823, 1000066430, 1000063347, 1000067984, 1000068071, 1000071417, 1000071430, 1000073434, 1000073436, 1000073438, 1000074660, 1000074661, 1000074662, 1000075553 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1455-2014%22
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