Drug product
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.
D-0861-2016
Product summary
- Event
- Event 73118
- Status
- Terminated
- Classification
- Class II
- Quantity
- 282,080 bags
- Official record key
drug-enforcement:D-0861-2016
Official wording
Reason: Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility.
Code information: Lot #: P337857, Exp 07/31/16
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility