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U.S. Department of Health and Human Services

Class 2 Device Recall InterX 5002, Sport, 1000, & Personal Sport packaged with Triad Alcohol Wipes

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  Class 2 Device Recall InterX 5002, Sport, 1000, & Personal Sport packaged with Triad Alcohol Wipes see related information
Date Initiated by Firm February 07, 2011
Date Posted April 28, 2011
Recall Status1 Terminated 3 on September 23, 2011
Recall Number Z-2105-2011
Recall Event ID 58255
510(K)Number k042912  
Product Classification Stimulator, nerve, transcutaneous, for pain relief - Product Code GZJ
Product Inter x 5002 Device, Inter x Professional Sport Device, Inter x 1000 Personal Device, and Inter x Personal Sport packaged with Triad alcohol wipes. The alcohol wipes manufactured by the Triad Group were labeled under brand names Triad, Select, Select Medical Products, PSS Select or PSS World Medical Inc.

Alcohol wipe is provided as a cleaning convenience for device electrodes.
Code Information All lots of the alcohol wipes.
Recalling Firm/
Manufacturer		 Neuro Resource Group Inc
1100 Jupiter Rd Ste 190
Plano TX 75074-7047
For Additional Information Contact
972-665-1810
Manufacturer Reason
for Recall		 Product package contains alcohol prep pads recalled by Triad Group because the prep pads have the potential to be contaminated with an objectionable organism.
FDA Determined
Cause 2		 Material/Component Contamination
Action Triad Group issued a press release on 2/7/2011, and notified consignees by e-mail 3/2/2011. Neuro Resource Group, Inc. ( NRG ) removed the recalled Triad wipes from all kits in house and obtained non recalled wipes from an alternate supplier. For replacement wipes customers may contact NRG customer service at 1-877-314-6500.
Quantity in Commerce 57,252 wipes
Distribution Worldwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GZJ and Original Applicant = NEURO RESOURCE GROUP, INC.
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