HIGH

B. Braun Sodium Chloride Injection Recalled Due to Sterility Issues

B. Braun Medical Inc. recalled 23,100 containers of 0.9% Sodium Chloride Injection on August 4, 2025. The recall stems from a lack of assurance of sterility and potential fluid leakage. This product is distributed nationwide in the United States.

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

Product Details

The recalled product is 0.9% Sodium Chloride Injection USP, L 8000, in a 1000mL Excel Container. It is a prescription-only, sterile, nonpyrogenic, single-dose container. The affected lot number is J5C919, with an expiration date of August 31, 2027.

The Hazard

The recall is due to a lack of assurance of sterility and the potential for fluid leakage at one of the weld sites. These issues pose health risks, particularly for patients who rely on sterile injections.

Reported Incidents

No specific incidents or injuries have been reported in connection with this recall as of the report date.

What to Do

Stop using the recalled product immediately. Contact B. Braun Medical Inc. or your healthcare provider for guidance on how to proceed. Notifications have been sent via letter.

Contact Information

For further information, contact B. Braun Medical Inc. at their official website or customer service number.

Key Facts

  • Recall date: August 4, 2025
  • Reported date: August 20, 2025
  • Quantity recalled: 23,100 containers
  • Lot number: J5C919
  • Expiration date: August 31, 2027
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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

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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