RECALL: Sage Products’ Comfort Shield Barrier Cream Cloths

Photo Credit: US Food and Drug Administration

CARY, Illinois (WHLT) – A nationwide recall is being expanded for Comfort Shield Barrier Cream Cloths.

Sage Products, based in Illinois, says an additional lot is affected and may be contaminated with the bacteria Burkholderia cepacia.

According to the US Food and Drug Administration the lots being recalled are the following:

Product Code                       NDC Number                    Lot Number                Expiration Date

7503                               53462-915-50                        53957                       3/6/2018

7905                               53462-915-80                        55781                       6/19/2018

The FDA’s recall statement reads as follows: “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.”

The products were distributed between March 31, 2016 through June 8, 2016 and between July 18, 2016 through July 19, 2016.

Anyone who received the recalled products should immediately discontinue their use and return them to Sage Products.  The company can be reached between 8:00am and 5:00pm Central Time.

 

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