Drug product
0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-10
D-0347-2023
Product summary
- Event
- Event 91658
- Status
- Completed
- Classification
- Class II
- Quantity
- 483,229 bags
- Official record key
drug-enforcement:D-0347-2023
Official wording
Reason: Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.
Code information: Lots: 0061794230 Exp. 01/31/2024; 0061794232 Exp. 01/31/2024; 0061797779 Exp. 02/29/2024; 0061797780 Exp. 02/29/2024; 0061797781 Exp. 02/29/2024; 0061797783 Exp. 02/29/2024; 0061797784 Exp. 03/31/2024; 0061797785 Exp. 03/31/2024; 0061797786 Exp. 03/31/2024; 0061797787 Exp. 03/31/2024; 0061797788 Exp. 03/31/2024; 0061809680 Exp. 04/30/2024
Distribution pattern: USA Nationwide.
Derived failure modes
-
Labeling or packaging
incomplete seal
-
Sterility assurance
Lack of sterility