Comfort Shield Barrier Cream Cloths; B. Cepacia Contamination

On August 1, 2016, Sage Products initiated a nationwide recall of one lot of Comfort Shield Barrier Cream Cloths to the distributor and health care facility/user level. The recall is being initiated due to product contamination with the bacteria, Burkholderia cepacia. Topical administration of a product with B. cepacia may cause serious infections in patients whose bodies cannot fight disease or in hospitalized patients, as well as certain other patient groups. These infections could be life-threatening.


Comfort Shield Barrier Cream Cloths are a non-sterile, topical skin protectant used to treat and prevent moisture associated skin irritation caused by urine and/or stool exposure. The recalled products were distributed to distributors and healthcare facilities in the United States.


This recall affects lots with Product Code 7503, NDC Number 53462-915-50, Lot Number 53957, and Expiration Date 3/6/2018. The affected lot was distributed to customers between March 31, 2016, and June 8, 2016.


See the FDA Safety Alert


Also see the Recall


See also Medical Law Perspectives, June 2016 Report: How Risky Is Going to the Hospital? The Dangers and Liabilities of Healthcare-Associated Infections