FDA-Device2021-06-02Class II
Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
Baxter Healthcare Corporation
Hazard
There is a potential leak between the venous patient connector and patient's hemodialysis access.
Sold states
Worldwide distribution - United States distribution and the countries of Canada, Korea, and Norway.
Affected count
17,487 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1684-2021Don't want to check this manually?
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