Sage Products Inc. issues a voluntary recall of Comfort Shield(r) Perineal Care Washcloths in the U.S. and Canada

Recall — Firm Press Release

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June 23, 2006 — /FDANews/ — Cary, IL — 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 // 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.

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

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