Worldwide Recall: Topical Skin Products Contaminated

Sage Products issued a worldwide recall of several types of topical skin products due to potential, life-threatening microbial contamination with the bacteria, Burkholderia cepacia. Items were distributed to at least 17 countries.

Sage Products announced that 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.

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 recalled products were distributed to distributors, healthcare facilities and retailers in the United States, Canada, El Salvador, Singapore, Saudi Arabia, Portugal, the Netherlands, Malaysia, Mexico, Australia, Ireland, Honduras, United Kingdom, Denmark, Germany, Bahrain, and United Arab Emirates.

The recalled products contain single-use, disposable cloths and were distributed between August 2014 and August 2016. The list of affected products and their corresponding lot numbers are indicated below.

Comfort Shield® Barrier Cream Cloths

Incontinence Clean-Up Cloth

M-care™ Meatal Cleansing Cloths for the Foley Catheterized Patient

Comfort Bath® Cleansing Washcloths

2% Chlorhexidine Gluconate Cloths

Sage Products is notifying distributors, healthcare facilities, retailers and consumers by letter, and they are being provided instructions to discontinue use and return product to Sage Products.

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. and 5:00 p.m., CDT.

Customers with questions regarding this recall, or requiring replacement product, should call Sage Products customer service at 1-800-421-6556, Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m., CDT. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products.

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Any adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report online.
Regular mail or fax: download form
or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: U.S. Food and Drug Administration