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D-0849-2026Class I

Baxter Healthcare Corporation

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Baxter Healthcare Corporation
Product type
Drug
Status
Ongoing
Report date
2026-09-09
Distribution
Natonwide in the USA
Firm state
IL
Product quantity
145,464 500mL bags
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Presence of particulate matter: Particulates identified as fiberglass

Product description

0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, Made in USA, NDC 0338-0049-03

Code / lot info

Lot: Y495523, Y495523A, Exp 31-Oct-2027

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →