Home / Recalls / B BRAUN MEDICAL INC / D-0653-2025

D-0653-2025 Class II Ongoing

Recalled by B BRAUN MEDICAL INC — Allentown, PA

Recall Details

Product Type
Drugs
Report Date
September 24, 2025
Initiation Date
August 26, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
16,228 3000 mL bags

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.

Reason for Recall

Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.

Distribution Pattern

U.S. Nationwide

Code Information

Lot#: : J4C521, J4C516, J4C524, Exp. : 28FEB2027.

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