WhichRecall
Class IIReported 2025-09-24

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

Recalled by B BRAUN MEDICAL INC

Reason for Recall

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

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Recall Number
D-0652-2025
Classification
Class II
Status
Ongoing
Category
drug
Initiated
2025-08-26
Reported
2025-09-24
Distribution
U.S. Nationwide
Code Info
Lot #: J3L519, J3L528, Exp.: 31AUG2026 Lot #: J4C522, J4C523, Exp.:28FEB2027
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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