FDA recall D-0517-2020
Baxter Healthcare Corporation · Class II · drug
Product
0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0047-29
Reason for recall
Lack of Assurance of Sterility: Product has the potential to leak.
Distribution
Nationwide within the United States
Key facts
- Status
- Terminated
- Initiation date
- 2019-11-19
- Report date
- 2019-11-27
- Termination date
- 2021-02-04
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Deerfield, IL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0517-2020