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.
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Consumers and healthcare providers should stop using this product immediately. Contact B BRAUN MEDICAL INC or your healthcare provider for guidance. Notification method: Letter
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 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.
No specific incidents have been reported thus far. However, the potential for contamination raises serious health concerns.
Stop using the product immediately. Contact B. Braun Medical Inc. or your healthcare provider for further guidance and instructions.
For assistance, call B. Braun Medical Inc. at their customer service number or visit their website for more information.
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Labeling: Incorrect or Missing Lot and/or Exp Date
Labeling: Incorrect or Missing Lot and/or Exp Date
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.