Status
Ongoing
Drug Enforcement D-0491-2025
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Classification
Class II
Report Date
July 2, 2025
Termination Date
—
Product Information
- Product description
- 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.
- Product quantity
- 187,656 containers
- Reason for recall
- Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- USA Nationwide
Location & Firm
- Recalling firm
- B BRAUN MEDICAL INC
- Address
-
861 Marcon Blvd
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0491-2025
- Event ID
- 97059
- Recall initiation date
- June 16, 2025
- Center classification date
- June 24, 2025
- Code info
- Lot #: J4L260, J4L261, J4L270, J4L271, J4L280, Exp 2/28/2027
- More code info
- —