D-0957-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 19, 2017
- Initiation Date
- July 6, 2017
- Termination Date
- April 29, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 131,904 bags
Product Description
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.
Distribution Pattern
Nationwide in USA
Code Information
Lot: Y229153, Exp 09/30/18