Date: August 19, 2016

URGENT: DRUG RECALL

Specific Lots of Topical Skin Products 

Recall Response Acknowledgement and Receipt Form
Distributor/Hospital Printable Form PDF
Consumer/At-Home-User Printable Form PDF

Lot Descriptions with Photos
Lot Descriptions with Photos PDF

Dear Distributor Partner or Healthcare Customer,

This website page was created to inform you of a voluntary worldwide product recall involving specific lots of impregnated cloth topical skin products manufactured by Sage Products. The recalled products were distributed between August 2014 and August 2016. The affected product codes and their corresponding lot numbers are attached to the Recall Response Acknowledgement and Receipt Form. For more information, you can click on the Lot Descriptions with Photos link above.

This recall is being initiated due to potential product contamination with Burkholderia cepacia

Topical administration of a product with presence of microbial contamination may cause serious infections in immunocompromised persons and in hospitalized patients, as well as certain other patient groups.

PLEASE TAKE THE FOLLOWING ACTIONS:

 IF YOU ARE A DISTRIBUTOR:

  • Check your inventory for the affected lot number. Lot numbers are located on the outside of the product case (over shipper). Discontinue use and/or further distribution of the affected lot.
  • If you have distributed this product to facilities or customers, please initiate your sub-recall process down to the facility or customer level.
  • Please complete the Recall Return Response and return it to Sage Products no later than September 16, 2016. This form must be completed even if you no longer have affected product.
  • If you have affected product, please return it to Sage Products.

IF YOU ARE A HEALTHCARE CUSTOMER:

  • Stop use of the affected lots of product immediately.
  • Check your inventory for the affected lot number. Lot numbers are located on the outside of the product case (over shipper) and on the side of the package. Discontinue use and/or further distribution of the affected lot.
  • Please complete the Recall Return Response and return it to Sage Products no later than September 16, 2016. This form must be completed even if you no longer have affected product.

ADDITIONAL INFORMATION:

The affected product should be returned to Sage Products for replacement or credit. Contact Sage Products Customer Service at 1-800-421-6556, Monday through Friday, between the hours of 8:00 a.m. to 5:00 p.m., Central Time.

Return unused product to:

Sage Products LLC
Attn: Customer Service Department – Recall
3909 Three Oaks Road
Cary, IL 60013

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. We regret any inconvenience this may have caused you or your firm. The Sage Products Customer Service team is standing by to assist you immediately.

Sincerely,

Sage Products LLC
Customer Service Department