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You are here: Home / Food Recalls / FDA Press Releases / Sage Products Inc. Recalls 2 Percent Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation

Sage Products Inc. Recalls 2 Percent Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation

July 1, 2008 By The FDA Leave a Comment

CONTACT: KYM AFFINITO OR MIKE NYGREN 815-455-4700

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

9705

10722

9707

10672

9705

10729

9707

10753

9706

10718

9707

10755

9707

10357

9707

10944

9707

10365

 

 

9707

10641

 

 

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

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Filed Under: FDA Press Releases

About The FDA

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.

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