FDA recall D-0431-2024
B. Braun Medical Inc · Class II · drug
Product
Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00
Reason for recall
Lack of assurance of sterility: bags have the potential to leak..
Distribution
Nationwide in the USA
Key facts
- Status
- Terminated
- Initiation date
- 2024-03-22
- Report date
- 2024-04-10
- Termination date
- 2025-07-01
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Irvine, CA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0431-2024