Major Recalls On Powdered Gloves, Saline Flush Announced
Silver Spring, MD and Haltom City, TX — The Food and Drug Administration (FDA) and Nurse Assist Inc. have both recently issued major recalls.
The FDA has recalled all powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon’s glove to take effect on January 18th.
According to the FDA, the products, “present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling.”
The recall, according to the Administration, will not have a negative environmental impact and will provide an estimated annual net benefit ranging around $30 million.
The full report on the recall can be found here.
Similarly, Nurse Assist Inc. has issued a voluntary recall on their Normal Saline Flush IV Syringes due to possible Burkholderia cepacia contamination. B. cepacia is a bacterium that can cause bloodstream infections, particularly in patients with weak immune systems.
According to the U.S. Centers for Disease Control and Prevention (CDC), the effects of B. cepacia on people, “vary widely, ranging from no symptoms at all to serious respiratory infections, especially in patients with cystic fibrosis.”
Because use of the affected products may cause serious adverse health consequences including bloodstream bacterial infections and death, the FDA has labeled this a Class I recall, the most severe type of recall. Continue>
Page | 1 2
Posted in: News Briefs | December 28, 2013
Posted in: News Briefs | March 6, 2014
Posted in: News Briefs | November 13, 2014