Sterile water for injection recalled over port misalignment allowing fluid leakage
B. Braun Sterile Water for Injection USP, 3000 mL bags, is recalled for lack of assurance of sterility because port misalignment may allow fluid leakage. 26,316 bags are affected.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; loss of sterility assurance in a sterile water product is a potential harm and no injuries are reported.
Plain-English summary
Sterile Water for Injection USP, 3000 mL, available on prescription only, from B. Braun Medical Inc. of Bethlehem, Pennsylvania, NDC 0264-7385-60, is being recalled. Affected lots are J3L519 and J3L528 expiring 31AUG2026 and J4C522 and J4C523 expiring 28FEB2027. The recall covers 26,316 bags distributed nationwide.
The recall was issued for lack of assurance of sterility, because of the potential for fluid leakage from the port due to port misalignment. The FDA classified the action as Class II.
Hospitals and pharmacies holding these lots should quarantine them, stop using them, and follow B. Braun's instructions for return or replacement.
The recalled product
- Product
- STERILE WATER (WATER)
- Brand
- STERILE WATER
- Manufacturer
- B BRAUN MEDICAL INC
- Category
- Drug — Intravenous Solution
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 (5)
- Lot #: J3L519
- J3L528
- Exp.: 31AUG2026 Lot #: J4C522
- J4C523
- Exp.:28FEB2027
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by B BRAUN MEDICAL INC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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