0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, Baxter Healthcare Co...
FDA Recall #D-481-2015 — Class I — December 4, 2014
Product Description
0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, Product Code 2B0043, NDC 0338-0553-18.
Reason for Recall
Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.
Recalling Firm
Baxter Healthcare Corp — Deerfield, IL
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
542,080 container bags
Distribution
Nationwide and Puerto Rico.
Code Information
Lot #: P317891, P317842, Exp 05/15
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated