FDA-Drug2023-07-19Class II

0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC 0264-5802-00

B. Braun Medical Inc.
Hazard

Lack of assurance of sterility: bags have the potential to leak.

Sold states
USA Nationwide
Affected count
79,880 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 18018-3524 USA, NDC 0264-5802-00

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0916-2023

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