FDA recall D-1335-2015

Product

0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.

Reason for recall

Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-07-17

Report date

2015-08-26

Termination date

2016-12-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1335-2015