0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0049-02

FDA recall notice · announced June 15, 2016 · Baxter Healthcare

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0049-02

Reason for recall

Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.

Notes

Distribution: Nationwide
Lot/code information: Lot # C980227; Exp. 11/16
Quantity: 255,852 VIAFLEX Plastic Containers
Status: Terminated
Products in this recall event:
- Dextrose Injection,USP,70% 2000 mL VIAFLEX Plastic Container Bag, Pharmacy Bulk Package, Not For Direct Infusion, Must Be Diluted, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL (D-0958-2016)
- 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0049-02 (D-0957-2016)

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