D-0586-2025 Class II Ongoing

Recalled by B BRAUN MEDICAL INC — Allentown, PA

Recall Details

Product Type
Drugs
Report Date
August 20, 2025
Initiation Date
August 4, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
23,100 containers

Product Description

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 Pattern

Nationwide in the US

Code Information

Lot #: J5C919, Exp. 08/31/2027