0.9% Sodium Chloride Injection, USP, packaged in a) 50 mL Single dose VIAFLEX plastic containers ...
FDA Recall #D-1163-2014 — Class I — November 21, 2013
Product Description
0.9% Sodium Chloride Injection, USP, packaged in a) 50 mL Single dose VIAFLEX plastic containers (Product code 2B1308, NDC 0338-0049-31) and b) 100 mL Single dose VIAFLEX plastic containers (Product code 2B1302, NDC 0338-0049-18) and (Product code 2B1309, NDC 0338-0049-38), Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.
Reason for Recall
Presence of Particulate 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
Recalling Firm
Baxter Healthcare Corp. — Deerfield, IL
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
716,544 containers
Distribution
Nationwide, Puerto Rico, Singapore, Saudi Arabia and United Arab Emirates.
Code Information
Lot #: a) P297283, Exp 08/14; b) P292326, Exp 04/14; P293993, Exp 05/14; and P293514, Exp 04/14
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated