PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: June 1, 2016 Initiated: January 21, 2016 #D-0861-2016

Product Description

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.

Details

Recalling Firm
Baxter Healthcare Corp.
Units Affected
282,080 bags
Distribution
Nationwide and Puerto Rico
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
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.. Recalled by Baxter Healthcare Corp.. Units affected: 282,080 bags.
Why was this product recalled?
Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 1, 2016. Severity: Moderate. Recall number: D-0861-2016.