Why it was recalled
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
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.
Lot numbers, UPCs & expiration codes
Lot#: : J4C521, J4C516, J4C524, Exp. : 28FEB2027.
Where it was sold
U.S. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0653-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 26, 2025
- FDA report date
- Sep 24, 2025
- Quantity
- 16,228 3000 mL bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- B BRAUN MEDICAL INC
Original FDA data
Every field from FDA enforcement report D-0653-2025, exactly as published.
Show all FDA fields
- City
- Allentown
- State
- PA
- Status
- Ongoing
- Country
- United States
- Event ID
- 97477
- Address
- 861 Marcon Blvd
- Code information
- Lot#: : J4C521, J4C516, J4C524, Exp. : 28FEB2027.
- Postal code
- 18109-9577
- Report date
- Sep 24, 2025
- Product type
- Drugs
- Recall number
- D-0653-2025
- Classification
- Class II
- Recalling firm
- B BRAUN MEDICAL INC
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Aug 26, 2025
- Initial firm notification
- Letter
- Center classification date
- Sep 16, 2025