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U.S. Department of Health and Human Services

Safety

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Sage Products Inc. Comfort Shield Perineal Care Washcloths

Audience: Hospital and Long-term care facility nursing supervisory staff

[Posted 06/26/2006] Sage Products and FDA notified healthcare professionals of a recall of specific lots of Comfort Shield Perineal Care Washcloths due to contamination with Burkholderia cepacia. Burkholderia cepacia can cause serious infections including pneumonia and bacterial sepsis in immuno-compromised persons, persons with cystic fibrosis, in hospitalized patients in general as well as certain other patient groups. The product was distributed to hospitals, medical centers and long-term care facilities in the U.S. and Canada. There was no known distribution through retail sales.

[June 23, 2006 – Press Release – Sage Products, Inc.]