FDA Issues Recall Alert for One Lot of 0.9% Sodium Chloride Irrigation, USP, 500 mL Plastic Pour Bottle Solution

Today, the Food and Drug Administration (FDA) alerted healthcare providers that Baxter International Inc. of Deerfield, Illinois, is voluntarily recalling one lot of 0.9% Sodium Chloride Irrigation, USP, 500 mL Plastic Pour Bottle solution to the hospital/user level. This product is being recalled due to a customer complaint prior to use for the presence of particulate matter, identified as an insect.

The recall affects the following lot:

Product Code

Product Description

Lot Number

Expiration Date

NDC

2F7123

0.9%, Sodium Chloride Irrigation, USP, 500 mL, Plastic Pour Bottle

G120162

11/30/2018

0338-0048-03

 

Sodium Chloride Irrigation solution with foreign material contamination potentially could result in a series of complications dependent in which anatomic location the irrigation is used, which could include inflammatory reaction, foreign body reaction, and infection which could be life-threatening.

To date, Baxter has not received any reports of adverse events related to this recall. 0.9% Sodium Chloride for Irrigation USP – 500 mL is an isotonic solution intended for irrigation. This solution can be used to rinse debris and residue from wounds and as a single use for rinsing/irrigation during surgical procedures. It may also be used to flush or rinse medical equipment such as catheters.

The lot being recalled was distributed to customers and distributors in the United States between November 12, 2015 and January 11, 2016.

Baxter is notifying its distributors and customers by letter that they should not use product from the recalled lot. Recalled product should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours of 7:00 a.m. and 6:00 p.m., CST. Unaffected lots of product are available for replacement.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by U.S. mail or by fax.

Please contact Ashley McGlone, manager of regulatory affairs, at 703-591-2220 if you have any questions.