FDA recall D-0973-2017

Product

0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Container, Rx Only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B1309, NDC: 0338-0049-38

Reason for recall

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

Distribution

Nationwide, Puerto Rico and Saudi Arabia

Key facts

Status

Terminated

Initiation date

2017-07-06

Report date

2017-07-19

Termination date

2020-04-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0973-2017