Baxter Healthcare product recalled over sterility concerns
- Recall date
- November 19, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Baxter Healthcare Corporation recalls 0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-…
- Recall number
- D-0517-2020
- FDA classification
- Class II
- Brand / firm
- Baxter Healthcare Corporation
- Sold / distributed
- Nationwide within the United States
Why it was recalled
Lack of Assurance of Sterility: Product has the potential to leak.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0047-29
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