FDA-Device2021-02-24Class II
Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 106289 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
Baxter Healthcare Corporation
Hazard
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
Sold states
Worldwide distribution.
Affected count
1460 devices
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 106289 - 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-1120-2021Don't want to check this manually?
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