Sage Products Recalls Medical Device for Bacterial Contamination

Sage Products Inc. has issued a recall of some lots of <"">2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation because it could be contaminated with the bacteria Burkholderia cepacia (B. cepacia). Customers who have these products should stop usage, sale and distribution, and should contact Sage Products to coordinate product return and replacement.

According to the company’s recall notice, the defective product was shipped to U.S. hospitals and medical centers nationwide between April 28 and June 19,2008. This voluntary recall of Sage 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation, is limited to the Product Code Numbers and corresponding Lot Numbers listed below:

Product Code Lot Number
9705             10722
9705             10729
9706             10718
9707             10357
9707             10365
9707             10641
9707             10672
9707             10753
9707             10755
9707             10944

B. cepacia poses little medical risk to healthy people. However, people who have certain health problems like 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 is not for oral or internal use. So far no illnesses have been reported in relation to this recalled device.

B cepacia has been implicated in product recalls in the past. In May, Hydrox Labs in Elgin, Illinois issued a voluntary recall of Cardinal Health-labeled alcohol-free mouthwash due to contamination with the bacteria. In 2005, the Centers for Disease Control (CDC) was notified by several states of clusters of pneumonia and other infections caused by B. cepacia and associated with contaminated mouthwash. In 2004, the CDC was notified of a voluntary recall of over-the-counter nasal spray due to contamination with B. cepacia complex.

In order to prevent this situation in the future, Sage Products has stopped accepting shipments of bulk 2% CHG solution from its outside supplier. The company says new product will be available for shipment as soon as July 7, 2008.

This entry was posted in Defective Medical Devices, Legal News, Product Recalls, Recalled Medical Devices. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.