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.
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.
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.
Since 1971, Sage Products has successfully developed and produced innovative prevention products that have significantly improved outcomes for patients and clinicians, while improving efficiency and profitability for healthcare facilities.
In 2016, Sage was acquired by Stryker Corporation and is a business within the Stryker Medical Division. Sage is a leading developer of products used to prevent hospital-acquired conditions such as skin injury due to incontinence, pressure ulcers, surgical site infections and healthcare worker injury.