Baxter Healthcare Corporation: Lack of Assurance of Sterility: Bags have the potential to leak.

Agency Publication Date: July 11, 2017

Affected Products

Product: 5% Dextrose Injection, USP, 100 mL VIAFLEX Plastic Container, Rx only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B0089, NDC: 0338-0017-38

Lot: P361618, Exp 09/30/18;

Lot Numbers:

P361618

Product: 0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Container, Rx Only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B1309, NDC: 0338-0049-38

Lots: P361501, P361667, and P361790, Exp 09/30/18

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 77676

Status: Resolved

Manufacturer: Baxter Healthcare Corporation

Manufactured In: United States

Units Affected: 2 products (54,528 bags; 295,200 bags)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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