FDA recall D-0957-2017

Product

0.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Distributed in Canada by Baxter Corporation, Toronto, Ontario, Canada, Product Code: 2B1322, NDC 0338-0049-02.

Reason for recall

Lack of Assurance of Sterility: Customer complaints for leaking bags.

Distribution

Nationwide in USA

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-0957-2017