FDAHealthDecember 22, 2025
Baxter Healthcare Corporation — Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.
⚠️ Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 22, 2025
Nationwide
What's affected?
- Product
- Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.
- Brand
- STERILE WATER
- Lot code
- G171359
Additional details
Lot #: G171359, expiry: 05/31/2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 125,496 bottles.
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