D-1514-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 31, 2019
- Initiation Date
- July 18, 2019
- Termination Date
- April 19, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 139,680 Containers
Product Description
0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38.
Reason for Recall
Lack of Assurance of Sterility: Bags have potential to leak.
Distribution Pattern
Nationwide in the United States and Puerto Rico.
Code Information
Lot #s: P389684; P389742, Exp. 8/31/2020