FDA recall D-0652-2025

B BRAUN MEDICAL INC · Class II · drug

Product

STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.

Reason for recall

Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.

Distribution

U.S. Nationwide

Key facts

Status
Ongoing
Initiation date
2025-08-26
Report date
2025-09-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Allentown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0652-2025