Sage Products Expands Recall Due to Potential B. cepacia Contamination
Sage Products has expanded a worldwide recall to include specific lots of impregnated cloth topical skin products.
Due to potential product contamination with the bacteria Burkholderia cepacia, Sage Products has expanded a worldwide recall to include specific lots of impregnated cloth topical skin products at all distributor, retail, and healthcare facility levels.
Topical administration of a product with B. cepacia may cause serious infections in patients whose body is unable to fight the disease; the infection can become life-threatening in certain patient groups.
Recalled products were distributed to retailers and healthcare facilities in the United States and Canada, as well as, El Salvador, Singapore, Saudi Arabia, Portugal, The Netherlands, Denmark, Germany, United Kingdom, and the United Arab Emirates.
The single-use, disposable cloths were distributed between August 2014 and August 2016:
- 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
A complete list of affected products and their corresponding lot numbers can be found in the company’s announcement via the US Food and Drug Administration’s (FDA) Recalls, Market Withdrawals, & Safety Alerts website. Customers who received affected products should discontinue use immediately and return to Sage Products for credit. Contact Sage Products customer service, (800) 421-6556 for more information.
Any adverse reactions experienced with the use of these products should be reported to the FDA’s MedWatch Adverse Event Reporting program. This recall is being conducted with the full knowledge of the FDA.