Recall: D-0586-2025

Class II - Potentially Harmful

Class IIClassification

2025-08-04Initiated

OngoingStatus

B BRAUN MEDICAL INCFirm

Product

0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7800-00.

Reason

Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.

Distribution

Nationwide in the US

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.