FDA-Drug2023-03-01Class II
0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00
B. Braun Medical Inc.
Hazard
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.
Sold states
USA Nationwide.
Affected count
1,343,982 bags
Manufactured in
1845 Mason Ave, N/A, Daytona Beach, FL, United States
Products
0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0346-2023Don't want to check this manually?
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