The Food and Drug Administration (FDA) has just announced (04/10/2015) that Baxter International Inc. has initiated recalls of select intravenous (IV) solutions for possible presence of particulate matter. Baxter manufacturing personnel, during a routine maintenance check, identified the defect. There have been no adverse events reported so far.

Particulate matter in IV solutions could lead to serious health consequences. The severity of the event would depend on the size of the particulate matter. According to the FDA, “In the absence of in-line filtration, these particles may cause: local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic embolization. In high-risk patients this may lead to serious adverse health consequences.”

The recalled products include several lots of 0.9% Sodium Chloride injection, USP (250ml), 5% and 10% Dextrose injection, USP (250ml), and Lactated Ringer’s injection, USP (250 ml).

For particular lot information, please refer to the FDA website listed in the “Reference” section.

Baxter International has requested that customers discontinue use of the affected lots and return the products for credit. Please call Baxter Healthcare Center for Service at 1-800-422-9837, Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m., Central Standard Time for more information. The email address for contacting Baxter International is onebaxter@baxter.com.

Please report any adverse events to FDA online: www.fda.gov/medwatch/report.htm.

 

 

Reference:

(2015 Apr 9). Baxter Initiates Voluntary Recall of Select Lots of IV Solutions Due to the Potential Presence of Particulate Matter. Retrieved from http://www.fda.gov/Safety/Recalls/ucm442074.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery