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Sage Recalls 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation

Ruzanna Harutyunyan's picture

As a precautionary measure, Sage Products announced a voluntary recall of limited lots of 2% Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product. Testing of bulk 2% CHG solution from an outside supplier was 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 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.

The recall includes the following products:

Product Code Number - Lot Number - Product Code Number - Lot Number

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9705 - 10722 - 9707 - 10672

9705 - 10729 - 9707 - 10753

9706 - 10718 - 9707 - 10755

9707 - 10357 - 9707 - 10944

9707 - 10365 - 9707 - 10641

Product was distributed to U.S. hospitals and medical centers nationwide. Affected product was shipped between 4/28/08 and 6/19/08. This voluntary recall is being conducted with the knowledge of the Food and Drug Administration. Sage Products has received no reports of patient injury. No other products from Sage are included in this recall.