FDA recall D-0869-2026

B BRAUN MEDICAL INC · Class I · drug

Product

0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018 USA, NDC 0264-1800-32.

Reason for recall

Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene

Distribution

Nationwide within the United States

Key facts

Status
Ongoing
Initiation date
2026-08-19
Report date
2026-09-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Allentown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0869-2026