B. Braun Medical, Inc. Provisional
FDA Flags (12)
Class II RecallApr 2025
B. Braun Medical Inc
0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Bra
Classification: Class II
Class I RecallAug 2024
B. Braun Medical Inc
0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-0
Classification: Class I
Class II RecallApr 2024
B. Braun Medical Inc
Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7
Classification: Class II
Class II RecallMar 2024
B. Braun Medical Inc
Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc.,
Classification: Class II
Class III RecallAug 2023
B. Braun Medical Inc.
0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, ND
Classification: Class III
Class II RecallJul 2023
B. Braun Medical Inc.
0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-352
Classification: Class II
Class II RecallMay 2023
B. Braun Medical Inc
Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Container, B.
Classification: Class II
Class II RecallMar 2023
B. Braun Medical Inc
Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.B
Classification: Class II
Class II RecallMar 2023
B. Braun Medical Inc.
0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, ND
Classification: Class II
Class II RecallMar 2023
B. Braun Medical Inc.
0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, N
Classification: Class II
Class II RecallDec 2022
B. Braun Medical, Inc.
0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehe
Classification: Class II
Class II RecallMar 2022
B. Braun Medical, Inc.
0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800
Classification: Class II