FDA recall D-0916-2023
B. Braun Medical Inc. · Class II · drug
Product
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
Reason for recall
Lack of assurance of sterility: bags have the potential to leak.
Distribution
USA Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2023-07-05
- Report date
- 2023-07-19
- Termination date
- 2024-04-23
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Daytona Beach, FL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0916-2023