Sage Products Expands Voluntary Worldwide Recall of Specific Lots of Topical Skin Products Due to Potential Microbial Contamination – Second Expansion
Sage Products 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.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
- To view the full list of affected products and their corresponding lot numbers, click here.
- To view the first press release with the initial recall, click here.
- To view the first recall expansion, click here.