Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Sage Products Inc. Issues Voluntary Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation
Kym Affinito or Mike Nygren
FOR IMMEDIATE RELEASE -- CARY, IL -- June 27, 2008 -- 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|
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.
Customers who have these products should stop usage, sale and distribution, and should contact Sage Products to coordinate product return and replacement. Additional information is posted at www.sageproducts.com/recall.
Sage Products Customer Service hotline: 1-800-421-6556.
Return unused product to:
Sage Products Inc.
C/O Customer Service Department
3909 Three Oaks Road, Cary, IL 60013