FDA recall D-0353-2025

B. Braun Medical Inc · Class II · drug

Product

0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-2201-10

Reason for recall

Presence of Particulate Matter

Distribution

Product was distributed to 12 distributors who may have further distributed the product nationwide.

Key facts

Status: Ongoing
Initiation date: 2025-03-31
Report date: 2025-04-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0353-2025