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As a precautionary measure, Sage Products has issued a voluntary recall of 2% Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative
Skin Preparation. During testing of bulk solution from an outside supplier, we discovered trace amounts of Burkholderia cepacia (B. cepecia).
The discovery was made using recently qualified, highly sensitive rapid micro method testing which is much more sensitive than the process initially approved by the FDA for testing this product. We immediately stopped production of our 2% CHG Cloth product. We reviewed testing records and confirmed that all 2% CHG Cloth product was within normal specifications when shipped, however new testing done on retained product from previous manufacturing lots were shown to contain trace amounts of B. Cepecia.
B. cepacia poses little medical risk to healthy people. However, people who have certain health problems like 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 is not for oral or internal use.
Antiseptic and disinfectant contamination with B. Cepecia has been reported in the literature for over 50 years. For this reason, we utilize rigorous testing methodologies and active surveillance on our products. CHG is proven effective against a broad spectrum of microorganisms, including MRSA, VRE, Acinetobacter, etc. However, history repeatedly demonstrates that given the opportunity, bacteria can learn how to survive in almost any environment, including antiseptic solutions.
In order to prevent this situation in the future, Sage Products has stopped accepting shipments of bulk 2% CHG solution from the outside supplier. New product will be available for shipment as soon as July 7, 2008.
Patient safety is of paramount concern at Sage Products. Therefore, we are taking an immediate, proactive approach to this situation by initiating this voluntary recall. The FDA has been notified of this action.
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