HIGHFDA DRUG

B. Braun 23,100 0.9% Sodium Chloride Injection Containers Recalled for Sterility Concerns (2025)

B. Braun Medical Inc. recalls 23,100 0.9% Sodium Chloride Injection L 8000 containers nationwide. The recall cites lack of assurance of sterility and potential fluid leakage at a weld site. Stop using immediately and consult a healthcare provider.

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
August 4, 2025
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

Recall Date
August 4, 2025
Hazard Level
HIGH
Brands
B. Braun Medical Inc., Sodium Chloride
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL, PREGNANT, PETS

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
B. Braun Medical Inc., Sodium Chloride
Product type
Intravenous Sodium Chloride Injection
Model numbers
Lot J5C919 Exp. 08/31/2027
UPC codes
0264-7800, 0264-7802, 0264-7800-00, 0264-7800-10, 0264-7800-20, 0264-7802-00, 0264-7802-10
Sizes
1000 mL
Sold at
Unknown
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    August 4, 2025

  2. Reported by FDA DRUG

    August 20, 2025

  3. RecallRadar source check

    April 18, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact B BRAUN MEDICAL INC or your healthcare provider for guidance. Notification method: Letter

About This Product

0.9% Sodium Chloride Injection is a sterile IV solution used for various medical purposes in clinical settings.

Why This Is Dangerous

A lack of sterility can lead to infections or sepsis in patients receiving the infusion. Fluid leakage at a weld site can compromise sterility and product integrity.

Industry Context

This recall is not listed as part of a broader industry pattern in the provided data.

Real-World Impact

High relevance for hospitals and clinics. Potential disruption to IV therapy supply and patient safety if used.

Practical Guidance

How to identify if yours is affected

  1. Locate lot J5C919 on the container
  2. Check expiration date 08/31/2027
  3. Confirm Excel container and 1000 mL size

Where to find product info

FDA recall page and manufacturer recall notice; NDC 0264-7800-00 on label

What timeline to expect

Processing of replacement or refunds will be determined by the manufacturer and healthcare facilities; expect multi-week turnaround

If the manufacturer is unresponsive

  • Escalate to hospital procurement lead
  • File adverse event report with FDA if event occurs
  • Consult distributor for replacement options

How to prevent similar issues

  • Verify lot numbers before administration
  • Maintain sterile handling procedures
  • Stock-only from approved supply chain
  • Review recall updates from FDA

Documentation advice

Keep copy of recall notice, lot J5C919, and expiration date; document communications with supplier and clinician

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Product Details

Lot number J5C919. Expiration 08/31/2027. 23,100 containers recalled. Excel Container, 1000 mL. NDC 0264-7800-00. Sold nationwide in the US. Class II recall.

Reported Incidents

No injury counts provided in the data.

Key Facts

  • Lot # J5C919
  • Nationwide distribution in the US
  • Class II recall

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANTPETS
Injury Types
POISONINGELECTRICALLACERATIONSUFFOCATION

Product Details

Model Numbers
Lot J5C919 Exp. 08/31/2027
UPC Codes
0264-7800
0264-7802
0264-7800-00
+4 more
Affected States
ALL
Report Date
August 20, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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