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Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Neuro Resource Group, Inc.
Informs Customers of Important Information
about Triad Group's Alcohol Prep Pads
FOR IMMEDIATE RELEASE - February 7, 2011 -Neuro Resource Group, Inc. (NRG) has become aware of the market recall of Triad Group's alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad in the United States and marketed under various brand names, (http://www.fda.gov/Safety/Recalls/ucm239219.htm). The Triad Group alcohol prep pads are co-packaged and distributed with NRG devices to customers in the United States and internationally.
According to the Food and Drug Administration's (FDA) Medwatch communication, the recall was initiated due to concerns about potential contamination of the Triad Group's products with the bacteria, Bacillus cereus. This recall involves those products marked as sterile as well as non-sterile. Use of contaminated alcohol prep pads, alcohol swabs, and alcohol swabsticks could lead to life-threatening infections, especially in at-risk populations, including immune suppressed and surgical patients. The Triad wipes may also be labeled “Select”; “Select Medical Products”; “PSS Select”, or “PSS World Medical, Inc.” The subject Triad/Select alcohol wipes previously provided with NRG devices should be discarded immediately. NRG is currently providing alcohol wipes that are not subject to recall.
It is important to note, that NRG devices are not contaminated and may continue to be used in accordance with the instructions for use. The alcohol wipes were provided strictly as a cleaning convenience. Patients and healthcare providers should not use the Triad/Select alcohol prep pads packaged with these devices and should instead use an alternate alcohol prep pad that is not involved with the Triad Group recall, or alternatively use a gauze or tissue pad in conjunction with 70% isopropyl alcohol for cleaning. For replacement wipes, customers may contact NRG customer service at 1-877-314-6500.
The company plans to issue a letter to customers to make them aware of the Triad product recall and the need to discontinue use of the Triad alcohol prep pads packaged with NRG products. Further information about the Triad Group recall can be found on the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239319.htm.
Patients should consult their healthcare provider for further information. Healthcare providers with questions may contact NRG Customer Service at 1-877-314-6500 between the hours of 8 am and 5 pm Central Time.
About Neuro Resource Group, Inc. Founded in 2004, NRG specializes in the development, design and manufacture of innovative medical products for injury management, rehabilitation, and pain management. The company is located in Plano, Texas. For additional information about the company, please visit http://www.nrg-unlimited.com.