Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 6
Summary
The FDA issued a Class II for Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxte by Baxter Healthcare Corporation. Reason: Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution.
Details
Source
Drug Recall
External ID
D-0296-2026
Action Date
2026-02-04
Status
Ongoing
Category
drug
Product Description
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.
Lot/Code Info: Lot #: G171359, expiry: 05/31/2027
Quantity Affected: 125,496 bottles
Reason for Recall
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2025-12-22
Company
Deerfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 35 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Baxter Healthcare Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Baxter Healthcare Corporation have FDA actions?
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0296-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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