Agency classClass IIOur severity:Moderate FDA (Drugs)·D-407-2014·Announced 2014-01-22

B. Braun Recalls Sodium Chloride Injection Due to Incorrect Bar Code Labeling

B. Braun Medical Inc. is recalling 19,572 bags of 0.45% Sodium Chloride Injection because the bar code incorrectly identifies the product as Potassium Chloride.

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 due to a labeling error (wrong bar code) that could lead to medication administration errors, but no specific injuries or illnesses are reported in the source text, fitting the 'Moderate' criteria for minor labeling errors or low-risk contamination.

Plain-English summary

B. Braun Medical Inc. is recalling 19,572 bags of 0.45% Sodium Chloride Injection USP, 1000 mL (NDC 0264-7802-00). The recall is due to a labeling error where the product's bar code scans as 0.15% Potassium Chloride in 0.9% Sodium Chloride (20 mEq K/liter) instead of the correct Sodium Chloride identification.

The affected product is Lot No. J3D548, with an expiration date of October 2015. The product was distributed nationwide in the United States and Puerto Rico. This is a prescription-only intravenous medication.

Healthcare providers and patients should check their inventory for this specific lot number and stop using the product if the bar code does not match the physical label. The FDA has classified this as a Class II recall, indicating a situation where use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: SODIUM CHLORIDE (SODIUM CHLORIDE)
Brand: SODIUM CHLORIDE
Manufacturer: B. Braun Medical Inc
Category: Drug — IV Solution
Hazard: mis-labeling
Affected units: 19,572

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 No. J3D548
expiry: Oct
2015

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same brand · SODIUM CHLORIDE

Critical
B. Braun Recalls Sodium Chloride Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-16
Critical
Baxter Recalls Sodium Chloride Injection Bags Due to Fiberglass Particulates
FDA (Drugs) · 2026-09-09
High
Spectra sodium chloride ampules recalled over lack of sterility assurance
FDA (Drugs) · 2026-04-22
High
Fresenius Kabi 500 mL saline freeflex bags recalled over sterility assurance
FDA (Drugs) · 2026-04-15
High
Fresenius Kabi half-normal saline 250 mL bags recalled over sterility assurance
FDA (Drugs) · 2026-04-15

Same manufacturer · B. Braun Medical Inc

See all →

Low
B Braun Recalls Discofix Stopcock Sets Due to Incorrect Expiration Date
FDA (Devices) · 2026-09-09
Severe
B. Braun Recalls Lactated Ringer's Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-02
Moderate
B. Braun UPMC double catheter trays contain Mastisol with cracking tubing
FDA (Devices) · 2026-06-10
Moderate
B. Braun spinal epidural kits contain Mastisol with cracking tubing
FDA (Devices) · 2026-06-10
Severe
Design Options spinal trays recalled over Huons bupivacaine quality issues
FDA (Devices) · 2026-06-10

Same hazard · mis labeling