Sage Products expands voluntary nationwide recall of Comfort Shield Barrier Cream Cloths due to microbial contamination
Nauss,Karen A (Mount Auburn)
Sage Products expands voluntary nationwide recall of Comfort Shield Barrier Cream Cloths due to microbial contamination
Sage Products announced 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.
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 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.
Visit FDA for the lot numbers and release.
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