Sterile Water for Injection bags recalled for sterility and leakage risk
B. Braun is recalling Sterile Water for Injection (3000mL) due to potential fluid leakage from port misalignment. This could compromise sterility and create contamination risk for IV patients.
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 of a sterile injectable product with potential loss of sterility assurance due to port misalignment causing fluid leakage. The product is a high-risk, high-hazard item (intravenous injection), fitting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.' Score 3 is appropriate because no illnesses or hospitalizations have been reported.
Plain-English summary
B. Braun Medical Inc. is recalling Sterile Water for Injection USP in 3000mL bags distributed nationwide. The affected lots are J3L519, J3L528 (expiring August 31, 2026) and J4C522, J4C523 (expiring February 28, 2027), representing 26,316 bags total.
The recall is due to a lack of assurance of sterility caused by potential fluid leakage from the injection port. Port misalignment during manufacturing could compromise the product's sterility, allowing fluid to leak out or contamination to enter the bags.
This product is administered intravenously and is used in healthcare settings. Patients who received Sterile Water from the affected lots should consult their healthcare provider. Healthcare facilities should immediately stop using the affected lots.
All healthcare providers and pharmacies should contact B. Braun Medical Inc. for return and replacement of the recalled product. For questions, contact B. Braun or the FDA.
The recalled product
- Product
- STERILE WATER (WATER)
- Brand
- STERILE WATER
- Manufacturer
- B BRAUN MEDICAL INC
- Category
- Drug — Injectable / IV Solution
- Hazard
- lack-of-sterility
- fluid-leakage
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.
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