Device 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.
Z-1455-2014
Product summary
- Event
- Event 67797
- Status
- Terminated
- Classification
- Class II
- Quantity
- 306,525 sets (20435 boxes of 15 sets)
- Official record key
device-enforcement:Z-1455-2014
Official wording
Reason: Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets.
Code information: Lot number: 1000039228, 1000048340, 1000050644, 1000050648, 1000054032, 1000058516, 1000064913, 1000065817, 1000065823, 1000066430, 1000063347, 1000067984, 1000068071, 1000071417, 1000071430, 1000073434, 1000073436, 1000073438, 1000074660, 1000074661, 1000074662, 1000075553
Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Canada, Mexico, and Colombia.
Derived failure modes
-
Unknown
Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets.