0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc....
FDA Recall #D-0346-2023 — Class II — February 10, 2023
Product Description
0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00
Reason for Recall
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.
Recalling Firm
B. Braun Medical Inc. — Daytona Beach, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1,343,982 bags
Distribution
USA Nationwide.
Code Information
Lots: 0061786962 Exp. 11/30/2023; 0061797767 Exp. 04/30/2024; 0061797768 Exp. 05/31/2024; 0061787769 Exp. 05/31/2024; 0061797770 Exp. 05/31/2024; 0061797771 Exp. 05/31/2024; 0061797772 Exp. 05/31/2024; 0061797773 Exp. 05/31/2024; 0061797774 Exp. 05/31/2024; 0061797775 Exp. 05/31/2024; 0061797776 Exp. 05/31/2024; 0061812946 Exp. 05/31/2024; 0061812947 Exp. 05/31/2024; 0061812948 Exp. 05/31/2024; 0061812949 Exp. 05/31/2024; 0061812950 Exp. 05/31/2024; 0061816017 Exp. 06/30/2024; 0061816018 Exp. 06/30/2024; 0061816019 Exp. 06/30/2024; 0061816020 Exp. 06/30/2024; 0061816021 Exp. 06/30/2024; 0061816358 Exp. 06/30/2024; 0061816359 Exp. 06/30/2024; 0061816361 Exp. 07/31/2024; 0061816362 Exp. 07/31/2024; 0061816363 Exp. 07/31/2024; 0061816364 Exp. 07/31/2024; 0061818516 Exp. 07/31/2024; 0061818517 Exp. 07/31/2024; 0061818518 Exp. 07/31/2024; 0061821562 Exp. 08/31/2024; 0061821563 Exp. 08/31/2024; 0061821564 Exp. 08/31/2024; 0061823709 Exp. 08/31/2024; 0061823710 Exp. 08/31/2024; 0061823711 Exp. 08/31/2024; 0061823714 Exp. 08/31/2024; 0061823715 Exp. 08/31/2024; 0061823716 Exp. 08/31/2024; 0061824770 Exp. 08/31/2024; 0061824771 Exp. 08/31/2024; 0061824772 Exp. 08/31/2024; 0061824773 Exp. 08/31/2024; 0061824774 Exp. 08/31/2024; 0061824775 Exp. 08/31/2024; 0061824776 Exp. 08/31/2024; 0061824777 Exp. 08/31/2024; 0061826486 Exp. 08/31/2024; 0061826487 Exp. 08/31/2024; 0061826488 Exp. 08/31/2024
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.