Sage Products announced a voluntary recall of one lot of Comfort Shield Barrier Cream Cloths due to contamination with the bacteria Burkholderia cepacia.
Comfort Shield Barrier Cream is a non-sterile, topical skin protectant used to treat and prevent moisture associated with skin irritation caused by urine and/or stool exposure. Topical administration with a contaminated product may lead to serious or life-threatening infections in patients who are hospitalized or cannot fight disease, as well as other patient groups.
The affected lot of products contain Product Code 7503, NDC 53462-915-50, Lot #53957 with expiration date 3/6/2018. This lot was distributed between March 31, 2016 and June 8, 2016. The package contains 3 single-use disposable cloths. The Company notified its distributors and healthcare facilities. Those with the recalled products should discontinue use and return them to Sage Products for credit.
Healthcare professionals and patients are encouraged to report adverse events related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. There have been no adverse events reported at this time.
For more information call (800) 421-6556 visit FDA.gov.