FDA-Drug2026-02-04Class II

Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.

Baxter Healthcare Corporation
Hazard

Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution

Sold states
Nationwide
Affected count
125,496 bottles
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0296-2026

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