D-0586-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- August 20, 2025
- Initiation Date
- August 4, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23,100 containers
Product Description
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.
Reason for Recall
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Distribution Pattern
Nationwide in the US
Code Information
Lot #: J5C919, Exp. 08/31/2027