Status
Ongoing
Drug Enforcement D-0586-2025
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Classification
Class II
Report Date
August 20, 2025
Termination Date
—
Product Information
- 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.
- Product quantity
- 23,100 containers
- Reason for recall
- Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the US
Location & Firm
- Recalling firm
- B BRAUN MEDICAL INC
- Address
-
861 Marcon Blvd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0586-2025
- Event ID
- 97368
- Recall initiation date
- August 4, 2025
- Center classification date
- August 14, 2025
- Code info
- Lot #: J5C919, Exp. 08/31/2027
- More code info
- —