B. Braun 0.9% Sodium Chloride Injection bags recalled for leaking
B. Braun Medical, Inc. is recalling 33,742 bags of 0.9% Sodium Chloride Injection USP due to leaking that compromises sterility assurance. The intravenous medication was distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall. Sterility assurance failure in an intravenous injection poses a direct risk of serious infection or harm if contaminated product is administered, meeting the criteria for a Severe classification even without reported illnesses.
Plain-English summary
B. Braun Medical, Inc. is recalling 0.9% Sodium Chloride Injection USP in 250 mL Excel containers due to a lack of sterility assurance caused by leaking bags. The recalled product (NDC 0264-7800-20) was distributed nationwide.
The specific lots affected are J1E086, J1E204, and J1E213 (expiring 5/31/2023), and J1H137 and J1H138 (expiring 6/30/2023). A total of 33,742 bags have been recalled.
Healthcare professionals and patients using affected lots should contact their pharmacy or healthcare provider. Patients should not use recalled bags and should return them to B. Braun Medical, Inc. or their supplier for replacement.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- B. Braun Medical, Inc.
- Category
- Drug — Intravenous Injection
- Hazard
- sterility-compromise
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot #: J1E086
- J1E204
- J1E213
- Exp 5/31/2023
- J1H137
- J1H138
- Exp 6/30/2023
Distribution
Distributed nationwide across the United States.
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