Sodium Chloride Injection (B Braun) – Sterility Compromise (2025)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.
Brand
B BRAUN MEDICAL INC
Lot Codes / Batch Numbers
Lot #: J4L260, J4L261, J4L270, J4L271, J4L280, Exp 2/28/2027
Products Sold
Lot #: J4L260, J4L261, J4L270, J4L271, J4L280, Exp 2/28/2027
B BRAUN MEDICAL INC is recalling 0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged due to Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026