Data Composite

Recall D-0432-2026

US Class II Ongoing · initiated 2026-03-11

Recalling firm

Fresenius Kabi USA, LLC, IL

Product

0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius Kabi"), IL 60047, Unit of Use NDC: 65219-432-20, Unit of Sale NDC Number: 65219-432-85.

Reason for recall

Lack of Assurance of Sterility

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