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.
Reason for recall: Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Recall initiated: 20250826
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated