FDAHealthJune 16, 2025
B BRAUN MEDICAL INC — 0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, ND
⚠️ Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 16, 2025
USA Nationwide
What's affected?
- Product
- 0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.
- Brand
- SODIUM CHLORIDE
- Lot code
- J4L260
Additional details
Lot #: J4L260, J4L261, J4L270, J4L271, J4L280, Exp 2/28/2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 187,656 containers.
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