Drug Enforcement D-0652-2025

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

Status

Ongoing

Classification

Class II

Report Date

September 24, 2025

Termination Date

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Product Information

Product description
STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
Product quantity
26,316 3000 mL bags
Reason for recall
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
U.S. Nationwide

Location & Firm

Recalling firm
B BRAUN MEDICAL INC
Address
861 Marcon Blvd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0652-2025
Event ID
97477
Recall initiation date
August 26, 2025
Center classification date
September 16, 2025
Code info
Lot #: J3L519, J3L528, Exp.: 31AUG2026 Lot #: J4C522, J4C523, Exp.:28FEB2027
More code info
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