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
0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B
🔢 16,228 3000 mL bags
Sold At: B BRAUN MEDICAL INC(U.S. Nationwide)
Recall #: FDA-DRUG-D-0653-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- Lot#: : J4C521, J4C516, J4C524, 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.