In latest medical and pharmaceutical news from the United States, Baxter Healthcare has issued a voluntary recall of its Buretrol Solution Sets. Buretrol solution sets are disposable, non-reusable, devices used for the administration of fluids from a container into the patient’s blood vessels (vascular system).

The move was taken after the company determined that the ball-valve component of the device had some manufacturing defects that were allowing air to flow past the valve and enter the tubing once the pre-measured amount of fluids is completely administered to the patient. The situation may worsen and may lead to even death if the air is not removed. One of the greatest fears with the product was that, the air present in the tubing can easily enter the blood and circulatory system of the patient potentially causing air bubble in the bloodstream leading to the formation of embolus in the blood.

Embolism is one of the most common reasons of heart attacks in the United States and there is a need to avoid causes and happenings that could increase such incidences. The products that were being recalled with this move were manufactured from April 30, 2003 through July 26, 2012 and were distributed from May 1, 2003 through August 16, 2012.

The move was announced by the manufacturer on September 7, 2012 and with this, Baxter Healthcare sent an Urgent Product Recall letter to affected customers informing them of the defective nature of the medical device. With this announcement the manufacturer has urged customers to stop using affected Buretrol Solution Sets. Patients and healthcare professionals having any query pertaining to the device could contact Baxter at 1-800-933-0303.

Patients and healthcare professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Else they can complete and submit their report online at: www.fda.gov/MedWatch/report.htm

Patients can download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

About Baxter: Baxter is a leader in healthcare equipments for more than 80 years. Baxter assists healthcare professionals and their patients with treatment of complex medical conditions.

About the Product: The discussed product Buretrol Solution Set is a prescription device that can only be obtained after you are prescribed by your doctor and have a duly signed and completed Prescription Drug Authorization (PDA) Form. Orders from individuals are not accepted at all. The Buretrol Solution Set comes complete with a 150mL interlink burette and 2 interlink injection sites 6″ and 30″ from male luer lock adapter. 60 drops per mL drip chamber filter valve. Tubing is compatible with the Colleague series volumetric infusion pumps and Flo-Gard 6201 and 6301 series volumetric infusion pumps. The overall length of the device is 105″.