Drug irrigation solution recalled due to sterility and port leakage risk
B. Braun Medical recalls Sodium Chloride irrigation solution due to potential fluid leakage from port misalignment that could compromise sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a sterility assurance defect with potential contamination from port leakage. No illnesses or injuries are reported. Per the rubric, this constitutes a risk-of-harm product where injury has not yet been reported, corresponding to High severity.
Plain-English summary
B. Braun Medical Inc. is recalling Sodium Chloride for Irrigation (0.9% isotonic solution for irrigation) distributed throughout the United States. The product is supplied in 3000 mL bags and is intended for medical irrigation applications. This recall affects approximately 16,228 units with lot numbers J4C521, J4C516, and J4C524, all expiring on February 28, 2027.
The recall is due to a lack of assurance of sterility. The issue stems from a manufacturing defect involving port misalignment, which could result in fluid leakage from the product's port. Such leakage could compromise the sterility of the irrigation solution.
The recalled product
- Product
- SODIUM CHLORIDE FOR IRRIGATION (SODIUM CHLORIDE FOR IRRIGATION)
- Brand
- SODIUM CHLORIDE FOR IRRIGATION
- Manufacturer
- B BRAUN MEDICAL INC
- Category
- Drug — Irrigation Solution
- Hazard
- fluid-leakage
- sterility-assurance
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot#: : J4C521
- J4C516
- J4C524
- Exp. : 28FEB2027.
Distribution
Distributed nationwide across the United States.
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