PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: December 14, 2022 Initiated: November 25, 2022 #D-0076-2023

Product Description

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

Reason for Recall

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

Details

Recalling Firm
B. Braun Medical, Inc.
Units Affected
756 bags
Distribution
FL, NJ, PA
Location
Allentown, PA

Frequently Asked Questions

What product was recalled?
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. Recalled by B. Braun Medical, Inc.. Units affected: 756 bags.
Why was this product recalled?
Lack of sterility assurance: Bags have the potential to leak.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 14, 2022. Severity: Moderate. Recall number: D-0076-2023.