FDA-Device2022-09-21Class I

Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.

Baxter Healthcare Corporation
Hazard

Firm noted an increase in customer reports of leaks.

Sold states
US Nationwide Distribution
Affected count
511,728 units
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1653-2022

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