Cary, IL, Sage Products announced recently it is expanding its voluntary nationwide recall to include an additional lot of Comfort Shield Barrier Cream Cloths at the distributor and healthcare 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. 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. The product, Comfort Shield Barrier Cream Cloths is a non-sterile, topical skin protectant used to treat and prevent moisture associated skin irritation caused by urine and/or stool exposure. The package contains single-use, disposable cloths. This recall affects the following lots of Comfort Shield Barrier Cream Cloths:
| Product Code | NDC Number | Lot Number | Expiration Date |
|---|---|---|---|
| 7503 | 53462-915-50 | 53957 | 3/6/2018 |
| 7905 | 53462-915-80 | 55781 | 6/19/2018 |
Sage Products notified its distributors and healthcare facilities by letter, and they were provided instructions to discontinue use and return product to Sage Products. The affected lots were distributed to customers between March 31 – June 8, 2016 and July 18 – July 19, 2016.
Customers who received affected products should discontinue use of the affected products and return them to Sage Products for credit by contacting Sage Products customer service at 1-800-421-6556, Monday through Friday, between the hours of 8:00 a.m. to 5:00 p.m., Central Time.
