FDAnews Device Daily Bulletin

SAGE PRODUCTS RECALLS COMFORT SHIELD PERINEAL CARE WASHCLOTHS IN U.S., CANADA

June 27, 2006
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The FDA and Cary, Ill.-based Sage Products June 23 announced a voluntary recall of lots of Comfort Shield Perineal Care washcloths shipped between Feb. 10 and May 19 to hospitals, medical centers and long-term care facilities in the U.S. and Canada. Some of the devices may be contaminated with Burkholderia cepacia, which can cause bacterial sepsis in people with weak immune systems, cystic fibrosis (CF), hospitalized patients and certain other patient groups, the company said. The recall was initiated after Sage received a complaint from Canada of an "off odor" in one lot of the products. There have been no reports of patient injury, the company said. FDA (http://www.fda.gov/oc/po/firmrecalls/sage06_06.html.)