Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corp...
FDA Recall #D-0296-2026 — Class II — December 22, 2025
Product Description
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.
Reason for Recall
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Recalling Firm
Baxter Healthcare Corporation — Deerfield, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
125,496 bottles
Distribution
Nationwide
Code Information
Lot #: G171359, expiry: 05/31/2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated