Agency classClass IOur severity:Critical FDA (Drugs)·D-0957-2016·Announced 2016-06-15

Baxter Recalls Sodium Chloride Injection Due to Insect Particulate Matter

Baxter Healthcare is recalling 255,852 bags of 0.9% Sodium Chloride Injection because customers reported finding an insect in the primary container.

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 agency classification is FDA Class I, which per the rubric mandates a score of 5 (Critical) regardless of other factors, as it represents a reasonable probability of serious adverse health consequences or death.

Plain-English summary

Baxter Healthcare Corporation is recalling 255,852 VIAFLEX Plastic Container Bags of 0.9% Sodium Chloride Injection, USP, 250 mL. The product is a prescription-only intravenous solution manufactured by Baxter Healthcare Corporation in Deerfield, IL. The specific lot affected is # C980227 with an expiration date of 11/16.

The recall was initiated due to confirmed customer complaints of finding an insect floating in the primary container of the product. This represents a presence of particulate matter in the sterile solution.

The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be quarantined and not used. Patients who have received the affected product should contact their healthcare provider for guidance.

The recalled product

Product: SODIUM CHLORIDE (SODIUM CHLORIDE)
Brand: SODIUM CHLORIDE
Manufacturer: Baxter Healthcare Corp.
Category: Drug — IV Solution
Hazard: particulate-matter
insect-contamination
Affected units: 255,852

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 (2)

Lot # C980227
Exp. 11/16

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Baxter Healthcare Corp. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same brand · SODIUM CHLORIDE

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Same manufacturer · Baxter Healthcare Corp.

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Same hazard · particulate matter