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Recall Observatory FDA recall evidence

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

February 10, 2023

Class II

Product summary

Firm
B. Braun Medical Inc.
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

    reason.labeling_packaging · v1.0.0

    incomplete seal
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility