FDA recall D-0655-2022
B. Braun Medical, Inc. · Class II · drug
Product
0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800-20
Reason for recall
Lack of sterility assurance: leaking bags
Distribution
USA Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2022-02-25
- Report date
- 2022-03-23
- Termination date
- 2023-03-16
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Allentown, PA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0655-2022