HIGH

B. Braun Medical Issues Recall for Sodium Chloride Irrigation Solution

B. Braun Medical Inc. recalled 16,228 bags of Sodium Chloride Irrigation Solution on August 26, 2025. The recall stems from a lack of assurance of sterility, posing a high risk of contamination. Consumers and healthcare providers should stop using the product immediately and seek guidance from B. Braun or their healthcare provider.

Quick Facts at a Glance

Recall Date
August 26, 2025
Hazard Level
HIGH
Brands
B. Braun Medical Inc., Sodium Chloride for Irrigation
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.

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

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Product Details

The recalled product is 0.9% Sodium Chloride Irrigation USP, supplied in 3000 mL bags. The affected lot numbers include J4C521, J4C516, and J4C524. These products distributed nationwide are prescription-only.

The Hazard

The recall is due to a lack of assurance of sterility and potential fluid leakage from the port caused by misalignment. This poses a risk of contamination, which can have serious health implications.

What to Do

Stop using the product immediately. Contact B. Braun Medical Inc. or your healthcare provider for further guidance and instructions.

Contact Information

For assistance, call B. Braun Medical Inc. at their customer service number or visit their website for more information.

Key Facts

  • Recall date: August 26, 2025
  • Total units recalled: 16,228
  • Affected lot numbers: J4C521, J4C516, J4C524
  • Risk level: High
  • Prescription only product

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
GENERAL
Injury Types
OTHER

Product Classification

Product TypeSodium Chloride Irrigation Solution
Sold At
Multiple Retailers

Product Details

Model Numbers
J4C521
J4C516
J4C524
UPC Codes
0264-7388
0264-7388-50
0264-7388-60
Affected States
ALL
Report Date
September 24, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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