MedWatch - 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation Product recalled: bacteria contamination
Sage Products informed healthcare professionals of the voluntary recall of limited lots of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation product. The product was recalled because certain lots were found positive for Burkholderia cepacia (B. cepacia). B. cepacia poses little medical risk to healthy people. However, people who have certain health problems such as a weakened immune system or chronic lung diseases, particularly cystic fibrosis (CF) may be more susceptible to infections with B. cepacia. This organism is a known cause of infections in hospitalized patients and its effects range from no symptoms to serious respiratory infections, especially in patients with CF. The product was distributed to U.S. hospitals and medical centers nationwide and was shipped between 4/28/08 and 6/19/08. Healthcare professionals should stop using the product and coordinate the return of the product with the manufacturer.
Read the complete MedWatch 2008 Safety Summary, including a link to the firm press release, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Chlorhexidine
Reviewed by Ramaz Mitaishvili, MD
