Sage Recalls 2% Chlorhexidine Gluconate Cloths for B. cepacia
June 30th, 2008 amy
Sage Products is recalling limited lots of 2% Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product because some tested positive for Burkholderia cepacia (B. cepacia).
Subject to the recall are:
- product number 9705, lot numbers 10722 and 10729
- product number 9706, lot number 10718
- product number 9707, lot numbers 10357, 10365, 10641, 10672, 10753, 10755, 10944
Product was distributed to U.S. hospitals and medical centers nationwide. Affected product was shipped between 4/28/08 and 6/19/08.
According to the FDA, B. cepacia poses little medical risk to healthy people. However, people who have certain health problems such as weakened immune systems or chronic lung diseases, particularly cystic fibrosis (CF), may be more susceptible to infections with B. cepacia. B cepacia is a known cause of infections in hospitalized patients. The effects of B. cepacia on people vary widely, ranging from no symptoms at all, to serious respiratory infections, especially in patients with CF. The intended application of the 2% CHG Cloth product is topical, for the skin only, and it is not for oral or internal use.
