FDA Drug Class II — Moderate

0.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Distributed in Canada by Baxter Corporation, Toronto, Ontario, Canada, Product Code: 2B1322, NDC 0338-0049-02.

Hazard

Lack of Assurance of Sterility: Customer complaints for leaking bags.

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Products

0.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Distributed in Canada by Baxter Corporation, Toronto, Ontario, Canada, P
Brand
Baxter Healthcare Corporation
UPC
Lot: Y229153, Exp 09/30/18

Units Affected

131,904 bags

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