Data Composite

Recall D-0433-2026

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) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distributed by: Fresenius Medical Care RTG, LLC, Manufactured by: Fresenius Kabi, Unit of Use NDC: 65219-282-01, Unit of Sale NDC Number: 65219-282-10.

Reason for recall

Lack of Assurance of Sterility

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