Date: July 29, 2016

URGENT: DRUG RECALL

Comfort Shield® Barrier Cream Cloths

Recall Response Acknowledgement and Receipt Form
– Printable PDF
– Editable Word Document

Dear Distributor Partner or Healthcare Customer,

This website page was created to inform you of a product recall involving Comfort Shield® Barrier Cream Cloths. Comfort Shield Barrier Cream Cloths are non-sterile, topical pre-moistened cloths that are intended to help seal out wetness, help treat and prevent perineal dermatitis, and protect from minor skin irritation associated with perineal dermatitis.

This recall affects the following lot of Comfort Shield Barrier Cream Cloths with 3% Dimethicone in flexible packaging:

Product Code NDC Number Lot Number Expiration Date
7503 53462-915-50 53957 3/6/2018

The affected lot was distributed to customers between March 31, 2016 and June 8, 2016.

This recall is being initiated due to potential product contamination with Burkholderia cepacia. To date, no adverse events associated with the recalled product have been reported, which were distributed to distributors and healthcare facilities in the United States.

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 enclosed Recall Return Response and return it to Sage Products no later than August 18, 2016. This form must be completed even if you no longer have affected product. This is an FDA requirement.
  • 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 enclosed Recall Return Response and return it to Sage Products no later than August 18, 2016. This form must be completed even if you no longer have affected product. This is an FDA requirement.

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