TRIAD GROUP – VOLUNTARY PRODUCT RECALL
JANUARY 5, 2011
FOR IMMEDIATE RELEASE – January 5, 2011 – Hartland, Wisconsin, Triad Group, a manufacturer of over-the-counter products has initiated a voluntary product recall involving ALL LOTS of ALCOHOL PREP PADS, ALCOHOL SWABS, and ALCOHOL SWABSTICKS manufactured by Triad Group but which are private labeled for many accounts to the consumer level. This recall involves those products marked as STERILE as well as non-sterile products. This recall has been initiated due to concerns from a customer about potential contamination of the products with an objectionable organism, namely Bacillus cereus. We are, out of an abundance of caution, recalling these lots to ensure that we are not the source of these contamination issues.
Use of contaminated Alcohol Prep Pads, Alcohol Swabs or Alcohol Swabsticks could lead to life-threatening infections, especially in at risk populations, including immune suppressed and surgical patients. To date we have received one report of a non-life-threatening skin infection.
Prep Pads, Swabs and Swabsticks containing alcohol, typically sold as 70%, act as surface sanitizers/disinfectants. Alcohol can readily kill vegetative non-spore forming cells, but spore forming microorganisms (spore forming bacteria and mold) are highly resistant. Alcohol may be filter sterilized to remove bacteria, yeast and mold prior to saturation of the various transfer devices; however, to assure a low bioburden content of the Prep Pads, Swabs and Swabsticks, these carriers should be irradiated to assure the removal of various spore forming microorganisms. Without the performance of both preventative measures, there is a high probability of spore forming microorganisms being present within either the alcohol, the alcohol carrier or both.
Since Bacillus cereus, a Gram positive spore former has been indicted as a potential contaminant of these carriers, all materials used as the active disinfectant, i.e., alcohol and carriers, should be confirmed to not contain bioburden by USP<61> Microbial Enumeration, and, if found to contain these microorganisms be irradiated using an approved AAMI gamma irradiation protocol and/or filter sterilized. (NOTE: Please also review the Recall for product that was suspected by the FDA of being contaminated — also with Bacillus cereus.)
FDA RELEASES 483 FOR TRIAD GROUP RECALL
The FDA on February 22, 2011 released a 30 page 483 for Triad Group which further explains the rationale behind the recall. You may access this document from http://www.fda.gov/downloads/AboutFDA/CentersOffices/ORA/ORAElectronicReadingRoom/UCM244257.pdf