Status
Terminated
Drug Enforcement D-0916-2023
Lack of assurance of sterility: bags have the potential to leak.
Classification
Class II
Report Date
July 19, 2023
Termination Date
April 23, 2024
Product Information
- Product description
- 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC 0264-5802-00
- Product quantity
- 79,880 bags
- Reason for recall
- Lack of assurance of sterility: bags have the potential to leak.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- USA Nationwide
Location & Firm
- Recalling firm
- B. Braun Medical Inc.
- Address
-
1845 Mason Ave, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0916-2023
- Event ID
- 92640
- Recall initiation date
- July 5, 2023
- Center classification date
- July 13, 2023
- Code info
- Lot#: 0061858305, 0061858306 Exp 3/31/2025
- More code info
- —