B. Braun Medical Inc. recalls 26,316 sterile water bags nationwide after discovery of potential leakage from misaligned ports. The recall covers 3000 mL bags with NDC 0264-7385-60. Health care providers are advised to stop use and contact the company for guidance.
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Consumers and healthcare providers should stop using this product immediately. Contact B BRAUN MEDICAL INC or your healthcare provider for guidance. Notification method: Letter
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Sterile water for injection is used to dilute or dissolve medications for intravenous administration in hospital settings.
Port misalignment can cause leakage and break sterility, risking infection if used for injection or dilution.
This recall is not part of a broader industry pattern.
Hospitals may experience supply disruption while ensuring sterility. Potentially requires replacement and monitoring for infection risk.
Recall notification letters and FDA enforce page provide details. Serial numbers and lot codes are printed on the packaging.
Refunds or replacements are determined by B. Braun policy; typical processing windows are communicated in recall notes.
Keep recall letter, photos of labels, lot numbers, dates, and shipping documents
Brand: B. Braun Medical Inc. Model numbers: Lot #: J3L519, J3L528; Lot #: J4C522, J4C523. Quantity: 26,316 bags. Size: 3000 mL. Type: Sterile Water for Injection USP. Sold nationwide in the U.S. Dates: Recall date 2025-08-26. Price: Unknown.
No injuries or incidents have been reported in the provided data.
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