0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfie...
FDA Recall #D-0517-2020 — Class II — November 19, 2019
Product Description
0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0047-29
Reason for Recall
Lack of Assurance of Sterility: Product has the potential to leak.
Recalling Firm
Baxter Healthcare Corporation — Deerfield, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
22336 bags
Distribution
Nationwide within the United States
Code Information
Lot #: Y309971, Y309971A, Exp. date 6/30/2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated