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URGENT: DRUG RECALL

Sage Products Limited Lot Voluntary Recall of Comfort Shield® Barrier Cream Cloths

Customer Service
Hotline: 1-800-421-6556
Fax: 1-815-455-5599
Email: recall@sageproducts.com

This recall affects the following lots of Comfort Shield Barrier Cream Cloths with 3% Dimethicone in flexible packaging or rigid tubs:

Product Code NDC Number Lot Number Expiration Date
7905 53462-915-80 44385 06/09/2016
7524 53462-915-60 44669 12/28/2015

The affected lots were distributed to customers between July 02, 2014 and August 19, 2014.

This recall is being initiated because Comfort Shield packages from the affected lots may be contaminated with bacteria. To date, no adverse events have been associated with the recalled products, which were distributed to distributors and healthcare facilities in the United States.

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

PLEASE TAKE THE FOLLOWING  ACTIONS:

  • Check your inventory for the affected lot numbers. Lot numbers are located on the outside of the product case (over shipper). View photo examples here. Discontinue use and/or further distribution of the affected lots.
  • If you have distributed this product to facilities or customers, please initiate your sub-recall process.
  • Please complete the enclosed Recall Return Response and return it to Sage Products no later than September 12, 2014.
    This form must be completed even if you no longer have affected product. This is an FDA requirement.

NOTIFICATIONS & DOCUMENTS:

Letter to Distributors
Letter to Healthcare Facilities
Recall Return Response Form

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
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. The Sage Products Customer Service team is standing by to assist you immediately.


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