Recalls / Class II
Class IID-0586-2025
Product
0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7800-00.
- Brand name
- Sodium Chloride
- Generic name
- Sodium Chloride
- Active ingredient
- Sodium Chloride
- Route
- Intravenous
- NDCs
- 0264-7800, 0264-7802
- FDA application
- NDA019635
- Affected lot / code info
- Lot #: J5C919, Exp. 08/31/2027
Why it was recalled
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Recalling firm
- Firm
- B BRAUN MEDICAL INC
- Manufacturer
- B. Braun Medical Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 861 Marcon Blvd, N/A, Allentown, Pennsylvania 18109-9577
Distribution
- Quantity
- 23,100 containers
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2025-08-04
- FDA classified
- 2025-08-14
- Posted by FDA
- 2025-08-20
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0586-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.