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.
What this means for you
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
- 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
Related recalls
Same brand · SODIUM CHLORIDE
- HighSpectra sodium chloride ampules recalled over lack of sterility assurance
FDA (Drugs) · 2026-04-22
- HighFresenius Kabi half-normal saline 250 mL bags recalled over sterility assurance
FDA (Drugs) · 2026-04-15
- HighFresenius Kabi 500 mL saline freeflex bags recalled over sterility assurance
FDA (Drugs) · 2026-04-15
- HighFresenius Kabi 100 mL sodium chloride freeflex bags recalled over sterility
FDA (Drugs) · 2026-04-15
- HighFresenius Kabi 1,000 mL sodium chloride bags recalled over sterility assurance
FDA (Drugs) · 2026-04-15
Same manufacturer · B. Braun Medical Inc
See all →- SevereB. Braun Recalls Lactated Ringer's Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-02
- ModerateB. Braun UPMC double catheter trays contain Mastisol with cracking tubing
FDA (Devices) · 2026-06-10
- ModerateB. Braun Shands kits contain Mastisol adhesive with cracking tubing
FDA (Devices) · 2026-06-10
- ModerateB. Braun spinal epidural kits contain Mastisol with cracking tubing
FDA (Devices) · 2026-06-10
- ModerateB. Braun kits contain Mastisol adhesive with potentially cracking tubing
FDA (Devices) · 2026-06-10
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02