Sterile Water for Injection bags recalled due to sterility concerns
B. Braun Medical Inc. is recalling Sterile Water for Injection USP 3000 mL bags (24,928 units) distributed nationwide due to lack of assurance of sterility and potential leakage from the diaphragm port.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class II recall of a parenteral pharmaceutical (intravenous sterile water) with a fundamental defect in assurance of sterility. Lack of sterility in injectable products poses serious risk of contamination, infection, or harm to patients, meeting the threshold for Severe classification even absent reported illnesses.
Plain-English summary
B. Braun Medical Inc. is recalling Sterile Water for Injection USP 3000 mL bags (Pharmacy Bulk Package, NDC 0264-7385-60) distributed nationwide. The affected product includes Lot J5H165 (expiration date 31 May 2028) and Lot J5E237 (expiration date 30 April 2028), totaling 24,928 bags.
The company identified that the product lacks assurance of sterility. Additionally, the diaphragm port may leak once the foil is removed, which could compromise product integrity.
Healthcare professionals and patients who have received this product should consult their healthcare provider if they have questions about potential exposure. The product is indicated for intravenous use and was distributed nationwide.
The recalled product
- Product
- STERILE WATER (WATER)
- Brand
- STERILE WATER
- Manufacturer
- B BRAUN MEDICAL INC
- Hazard
- lack-of-sterility
- product-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 (4)
- Lot # J5H165
- Exp Date: 31 May2028
- Lot # J5E237
- Exp Date: 30APR2028.
Distribution
Distributed nationwide across the United States.