0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx Only, Manufactured ...
FDA Recall #D-0957-2016 — Class I — December 15, 2015
Product Description
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.
Recalling Firm
Baxter Healthcare Corp. — Deerfield, IL
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
255,852 VIAFLEX Plastic Containers
Distribution
Nationwide
Code Information
Lot # C980227; Exp. 11/16
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated