Agency classClass IOur severity:Severe FDA (Drugs)·D-1335-2015·Announced 2015-08-26

Baxter Recalls Sodium Chloride Injection Bags Due to Insect Contamination

Baxter Healthcare is recalling 133,600 bags of 0.9% Sodium Chloride Injection USP due to the presence of an insect.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. The presence of an insect in an intravenous injection bag poses a significant risk of infection or other serious injury.

Plain-English summary

Baxter Healthcare Corporation is recalling 133,600 bags of 0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags. The recall is being conducted because of a customer complaint regarding an insect found free floating inside a single bag for each lot recalled.

The affected product is identified by Product Code 2B0043, NDC 0338-0553-18, Lot Number P327635, and an expiration date of 12/15. The product is distributed nationwide and is available by prescription only.

Healthcare providers and consumers should stop using the affected product and contact Baxter Healthcare Corporation for further instructions or a replacement.

The recalled product

Product: SODIUM CHLORIDE (SODIUM CHLORIDE)
Brand: SODIUM CHLORIDE
Manufacturer: Baxter Healthcare Corp.
Category: Drug — IV Fluids
Hazard: foreign-object
insect-contamination
Affected units: 133,600

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#: P327635
Exp 12/15

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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Fresenius Kabi 100 mL sodium chloride bags for BD recalled over sterility
FDA (Drugs) · 2026-04-15

Same manufacturer · Baxter Healthcare Corp.

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Same hazard · foreign object