FDA recall D-0586-2025

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 for recall

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

Distribution

Nationwide in the US

Key facts

Status

Ongoing

Initiation date

2025-08-04

Report date

2025-08-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Allentown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0586-2025