Description
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