FDA recall D-0497-2026

B BRAUN MEDICAL INC · Class II · drug

Product

0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.

Reason for recall

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

Distribution

US Nationwide.

Key facts

Status
Ongoing
Initiation date
2026-04-02
Report date
2026-04-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Allentown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0497-2026