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.

FDA recall notice · announced July 19, 2017 · Baxter Healthcare

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Reason for recall

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

Notes

Distribution: Nationwide in USA
Lot/code information: Lot: Y229153, Exp 09/30/18
Quantity: 131,904 bags
Status: Terminated
Products in this recall event:
- 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, Pr (D-0957-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.