FDA-Drug2022-12-14Class II

0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862

B. Braun Medical, Inc.
Hazard

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

Sold states
FL, NJ, PA
Affected count
756 bags
Manufactured in
901 Marcon Blvd, N/A, Allentown, PA, United States
Products
0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0076-2023

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