Agency classClass IOur severity:Critical FDA (Drugs)·D-0849-2026·Announced 2026-09-09

Baxter Recalls Sodium Chloride Injection Bags Due to Fiberglass Particulates

Baxter Healthcare is recalling 0.9% Sodium Chloride Injection bags because fiberglass particulates were identified in the product.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text explicitly identifies the agency classification as 'Class I', which mandates a severity score of 5 according to the rubric.

Plain-English summary

Baxter Healthcare Corporation is recalling 0.9% Sodium Chloride Injection USP 500 mL VIAFLEX Plastic Containers. The recall involves 145,464 bags distributed nationwide in the United States. The specific lots affected are Y495523 and Y495523A, with an expiration date of October 31, 2027.

The reason for the recall is the presence of particulate matter, specifically identified as fiberglass, within the product. This is an FDA Class I recall, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death.

Healthcare providers and facilities should check their inventory for the affected lot numbers and stop using the product. Patients who have received this product should contact their healthcare provider if they experience any adverse effects.

The recalled product

Product: SODIUM CHLORIDE (SODIUM CHLORIDE)
Brand: SODIUM CHLORIDE
Manufacturer: Baxter Healthcare Corporation
Category: Drug — IV Fluids
Hazard: particulate-matter
fiberglass

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

Lot: Y495523
Y495523A
Exp 31-Oct-2027

Distribution

Distribution scope not specified by the agency.

Same brand · SODIUM CHLORIDE

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