Safety Alert: Class II: Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
healthClass IIRecalled on Sep 24, 2025
STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
🔢 26,316 3000 mL bags
Sold At: B BRAUN MEDICAL INC(U.S. Nationwide)
Recall #: FDA-DRUG-D-0652-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- Lot #: J3L519, J3L528, Exp.: 31AUG2026 Lot #: J4C522, J4C523, Exp.:28FEB2027
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Summary
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
What to do next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact B BRAUN MEDICAL INC for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.