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U.S. Department of Health and Human Services

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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 a Voluntary Recall of Comfort Shield? Perineal Care Washcloths in the U.S. and Canada

Contact:
Sage Products Inc.
1-800-323-2220

FOR IMMEDIATE RELEASE -- Cary, IL -- June 23, 2006 -- Sage Products Inc., of Cary, Illinois, is initiating a voluntary recall of specific lots of Comfort Shield Perineal Care Washcloth product codes due to contamination with Burkholderia cepacia. See identified lots, below.  

Code #

Lot #

Dates shipped

7403

1301

02/10/06 - 02/13/06

7403

1312

02/13/06 - 03/02/06

7403

1312

02/13/06 - 03/02/06

7403

1457

02/24/06 - 03/01/06

7403

1677

05/02/06 - 05/03/06

7408

1848

04/18/06

7503

1999

05/03/06 - 05/16/06

7524

2070

05/01/06 - 05/15/06

7524

2086

05/11/06 - 05/15/06

7905

1766

03/22/06 - 06/12/06

7503-M

1702

04/13/06

7503-M

1995

04/13/06 - 05/19/06

Burkholderia cepacia can cause serious infections including pneumonia and bacterial sepsis in immunocompromised persons, persons with cystic fibrosis (CF), in hospitalized patients in general as well as certain other patient groups. No other lots of Comfort Shield Perineal Care Washcloths from Sage Products are known to be affected by this recall.

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. Sage Products initiated this recall after receiving and investigating a Canadian complaint on lot 1457 of off odor. At the present time, Sage Products Inc has received no reports of patient injury. This voluntary recall is being conducted with the knowledge of the Food and Drug Administration.

Customers who have the affected lots of these products should stop usage, sale and distribution, and should contact Sage Products to coordinate product return and replacement. Product is available for immediate replacement and no stock outage is anticipated. To arrange for product replacement, contact Customer Service at 1-800-323-2220. Return affected product only, to Sage Products Inc, 3909 Three Oaks Road, Cary, IL 60013, attention: Customer Service.

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