Status
Terminated
Drug Enforcement D-0076-2023
Lack of sterility assurance: Bags have the potential to leak.
Classification
Class II
Report Date
December 14, 2022
Termination Date
August 23, 2024
Product Information
- Product description
- 0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862
- Product quantity
- 756 bags
- Reason for recall
- Lack of sterility assurance: Bags have the potential to leak.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- FL, NJ, PA
Location & Firm
- Recalling firm
- B. Braun Medical, Inc.
- Address
-
901 Marcon Blvd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0076-2023
- Event ID
- 91194
- Recall initiation date
- November 25, 2022
- Center classification date
- December 5, 2022
- Code info
- Lot: 0061832446 Exp. 31 Oct 2024
- More code info
- —