D-0861-2016 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 1, 2016
- Initiation Date
- January 21, 2016
- Termination Date
- February 26, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 282,080 bags
Product Description
0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.
Reason for Recall
Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot #: P337857, Exp 07/31/16