Baxter Healthcare Recalls Sterile Water for Irrigation Due to Plastic Particulate Matter

What Happened

Baxter Healthcare Corporation has voluntarily initiated a recall of Sterile Water for Irrigation. The recall was prompted by the discovery of particulate matter, specifically plastic particles from the bottle rim, which were observed floating within the sterile solution. This recall has been classified by the FDA as Class II.

Which Products Are Affected

The recall affects 125,496 bottles of the following product:

• Product Name: Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle (Rx Only)
• NDC: 0338-0004-02
• Lot Number: G171359
• Expiration Date: 05/31/2027
• Recall Number: D-0296-2026

The product was distributed nationwide throughout the United States.

What You Should Do

Healthcare providers and consumers are advised to immediately stop using the affected lot. Baxter Healthcare Corporation notified customers of the recall via letter. Those in possession of the recalled product should follow the instructions provided in the notification for the return or disposal of the bottles. For additional inquiries, contact Baxter Healthcare Corporation at their headquarters in Deerfield, Illinois.

Why This Matters

The presence of foreign plastic particles in a sterile irrigation solution can lead to physical irritation, inflammation, or other complications if used during medical procedures. A Class II classification indicates that the use of the product may cause temporary or medically reversible adverse health consequences.

Source

Information sourced from the FDA.