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Triad Sterile Lubricating Jelly: Recall - Product May Not Be Sterile

Wed, 02/16/2011 - 6:34am
U.S. Food & Drug Administration

 

AUDIENCE: Risk Manager

ISSUE: These products may not be sterile. Patients who are immuno-compromised, such as those with diabetes, cancer and certain other chronic diseases, may be at potential risk for infection.

BACKGROUND: Triad lubricating jelly products were distributed by Triad from January, 2007 through December 2010. These products may be contained in kits, packs, or trays that have been packaged after December 2010 by other firms.

RECOMMENDATION: Immediately contact your kit, pack or tray suppliers to determine whether the products stocked at your facility are impacted by the Triad recall. Your supplier should provide you with documentation on whether your products are affected by the recall.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

[02/15/2011 - Recall Notice - FDA]

    

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