FDA recall D-1514-2019

Baxter Healthcare Corporation · Class II · drug

Product

0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38.

Reason for recall

Lack of Assurance of Sterility: Bags have potential to leak.

Distribution

Nationwide in the United States and Puerto Rico.

Key facts

Status
Terminated
Initiation date
2019-07-18
Report date
2019-07-31
Termination date
2021-04-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1514-2019