Sage Products is voluntarily expanding a recall of certain lots of Comfort Shield Barrier Cream Cloths due to contamination with a bacteria called Burkholderia cepacia. To date, no adverse events have been reported associated with the recalled products, which were distributed to distributors and healthcare facilities in the United States, according to the FDA recall notice. Comfort Shield Barrier Cream Cloths are single-use, disposable cloths used to treat and prevent moisture associated skin irritation caused by urine and/or stool exposure.
This recall affects the following lots of the cloths:
|Product Code||NDC Number||Lot Number||Expiration Date|
The affected lots were distributed to customers between March 31 - June 8, 2016 and July 18 - July 19, 2016. Sage Products notified its distributors and healthcare facilities by letter, and they were provided instructions to discontinue use and return product to Sage Products.