FDA recall D-0861-2016

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

Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2016-01-21

Report date

2016-06-01

Termination date

2018-02-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0861-2016