STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
Reported: September 24, 2025 Initiated: August 26, 2025 #D-0652-2025
Product Description
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.
Details
- Recalling Firm
- B BRAUN MEDICAL INC
- Units Affected
- 26,316 3000 mL bags
- Distribution
- U.S. Nationwide
- Location
- Allentown, PA
Frequently Asked Questions
What product was recalled? ▼
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. Units affected: 26,316 3000 mL bags.
Why was this product recalled? ▼
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 24, 2025. Severity: Moderate. Recall number: D-0652-2025.
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