UPDATED: Sage Products Issues Recall of Cloths Due to Microbial Contamination
The microbe may cause serious, even life-threatening, infections
Sage Products has announced 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 Burkholderia cepacia.
Topical administration of a product with this bacterium 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.
The product 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 three single-use disposable cloths. The affected product has been assigned product code 7503, National Drug Code (NDC) number 53462-915-50, lot number 53957 and expiration date 3/6/2018. It was distributed to customers between March 31, 2016 and June 8, 2016.
Sage Products notified its distributors and health care facilities by letter, and they were provided instructions to discontinue use and return product to the company.
Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Customers should discontinue use of the affected products and return them to the company for credit by contacting the company's customer service department.
For questions or to return the recalled product, Sage Products Customer Service can be reached at (800) 421-6556.
Update: Sage Products announced today it is expanding its voluntary worldwide recall to include specific lots of impregnated cloth topical skin products at the distributor, healthcare facility, retail, and consumer/user levels. The recall is being initiated due to potential product contamination with the bacteria Burkholderia cepacia.
The recalled products contain single-use, disposable cloths and were distributed between August 2014 and August 2016.
See the new FDA release for the list of affected products and their corresponding lot numbers.