FDA Drug Class II — Moderate

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.

Hazard

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

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Products

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
B BRAUN MEDICAL INC
UPC
Lot#: : J4C521, J4C516, J4C524, Exp. : 28FEB2027.

Units Affected

16,228 3000 mL bags

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