PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: April 15, 2015 Initiated: December 4, 2014 #D-481-2015

Product Description

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

Reason for Recall

Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.

Details

Recalling Firm
Baxter Healthcare Corp
Units Affected
542,080 container bags
Distribution
Nationwide and Puerto Rico.
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, Product Code 2B0043, NDC 0338-0553-18.. Recalled by Baxter Healthcare Corp. Units affected: 542,080 container bags.
Why was this product recalled?
Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 15, 2015. Severity: Critical. Recall number: D-481-2015.