FDA recall D-1162-2014

Product

5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product code 2B0089, NDC 0338-0017-38.

Reason for recall

Presence of Paticulate Matter; Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag

Distribution

Nationwide, Puerto Rico, Singapore, Saudi Arabia and United Arab Emirates.

Key facts

Status

Terminated

Initiation date

2013-11-21

Report date

2014-03-26

Termination date

2016-09-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1162-2014