Devices

Device Recall Gambro Cartridge Blood Set

Model / Serial
Lot number: 1000039228, 1000048340, 1000050644, 1000050648, 1000054032, 1000058516, 1000064913, 1000065817, 1000065823, 1000066430, 1000063347, 1000067984, 1000068071, 1000071417, 1000071430, 1000073434, 1000073436, 1000073438, 1000074660, 1000074661, 1000074662, 1000075553
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Canada, Mexico, and Colombia.
Product Description
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.
Manufacturer
Gambro Renal Products, Incorporated
1 Event
- Recall of Device Recall Gambro Cartridge Blood Set

Manufacturer

Gambro Renal Products, Incorporated

Manufacturer Address
Gambro Renal Products, Incorporated, 14143 Denver West Pkwy, Lakewood CO 80401-3266
Manufacturer Parent Company (2017)
Baxter International
Source
USFDA

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