Official recall notice
FDA DrugClass IINotable
FDA Recall: Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc.
- Recall date
- 2026-04-29
- Brand
- B BRAUN MEDICAL INC
- Category
- Drug
- FDA class
- Class II
Why it was recalled
Hazard
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Recommended action
What to do
24,928 bags
Product description
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.