HIGH

B. Braun Medical Recalls Lactated Ringer's Injection Due to Sterility Concerns

B. Braun Medical Inc. recalled 74,088 containers of Lactated Ringer's Injection on August 4, 2025. The recall stems from a lack of assurance of sterility and potential fluid leakage. Consumers and healthcare providers should discontinue use immediately and seek guidance.

Quick Facts at a Glance

Recall Date
August 4, 2025
Hazard Level
HIGH
Brands
B. Braun Medical Inc., Lactated Ringers
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 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

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Product Details

The recall affects Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only. The affected lot numbers include J5C802, J5C917, and J5C918, with an expiration date of August 31, 2027.

The Hazard

The product poses a high risk due to the lack of assurance of sterility. There is also a potential for fluid leakage at one of the weld sites.

Reported Incidents

No specific incidents or injuries related to this recall have been reported, but the potential risks warrant immediate action.

What to Do

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

Contact Information

For more information, visit the FDA website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0585-2025.

Key Facts

  • 74,088 containers recalled
  • Expiration date: 08/31/2027
  • Lack of sterility assurance
  • Potential fluid leakage risk

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Safety Assessment

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

Product Classification

Product Details

Model Numbers
J5C802
J5C917
J5C918
UPC Codes
0264-7750
0264-7750-00
0264-7750-10
+1 more
Affected States
ALL
Report Date
August 20, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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