Recalls / Class II
Class IID-0653-2025
Product
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.
- Brand name
- Sodium Chloride For Irrigation
- Generic name
- Sodium Chloride For Irrigation
- Active ingredient
- Sodium Chloride
- Route
- Irrigation
- NDC
- 0264-7388
- FDA application
- NDA016733
- Affected lot / code info
- Lot#: : J4C521, J4C516, J4C524, Exp. : 28FEB2027.
Why it was recalled
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
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
- 16,228 3000 mL bags
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2025-08-26
- FDA classified
- 2025-09-16
- Posted by FDA
- 2025-09-24
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0653-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.