Status
Ongoing
Drug Enforcement D-0653-2025
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Classification
Class II
Report Date
September 24, 2025
Termination Date
—
Product Information
- Product description
- 0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, NDC 0264-7388-60.
- Product quantity
- 16,228 3000 mL bags
- Reason for recall
- Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- U.S. Nationwide
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-0653-2025
- Event ID
- 97477
- Recall initiation date
- August 26, 2025
- Center classification date
- September 16, 2025
- Code info
- Lot#: : J4C521, J4C516, J4C524, Exp. : 28FEB2027.
- More code info
- —