Agency classClass IIOur severity:Moderate FDA (Drugs)·D-623-2013·Announced 2013-07-03

Baxter Recalls 0.9% Sodium Chloride Injection Due to Barcode Labeling Error

Baxter Healthcare is recalling 317,280 bags of 0.9% Sodium Chloride Injection because the barcode may incorrectly identify the product as 100 mL instead of 50 mL.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a minor labeling error that is unlikely to cause serious adverse health consequences but could lead to a temporary or medically reversible health risk.

Plain-English summary

Baxter Healthcare Corporation is recalling 317,280 bags of 0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container. The recall is due to a labeling error where the barcode may display the wrong product code, reflecting the 100 mL volume instead of the correct 50 mL volume.

The affected product is identified by Lot P293118 with an expiration date of 10/13. The product is distributed nationwide and in Singapore. The error is limited to the barcode labeling and does not indicate a change in the actual contents of the bag.

Healthcare providers and patients should verify the product volume against the physical label and not rely solely on the barcode for identification. If the product is found to have the incorrect barcode, it should be returned to the distributor or manufacturer for replacement or credit.

The recalled product

Product: SODIUM CHLORIDE (SODIUM CHLORIDE)
Brand: SODIUM CHLORIDE
Manufacturer: Baxter Healthcare Corp.
Category: Drug — IV Fluids
Hazard: mis-labeling
Affected units: 317,280

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: P293118
Exp Date: 10/13

Distribution

Distributed nationwide across the United States.

Same brand · SODIUM CHLORIDE

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