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0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun ...

FDA Recall #D-0653-2025 — Class II — August 26, 2025

Recall #D-0653-2025 Date: August 26, 2025 Classification: Class II Status: Ongoing

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.

Recalling Firm

B BRAUN MEDICAL INC — Allentown, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

16,228 3000 mL bags

Distribution

U.S. Nationwide

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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