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.
FDA Recall Z-2105-2011 · Posted 2011-04-28
Recalling FirmNeuro Resource Group Inc
Recall StatusTerminated
Product CodeGZJ
Date Initiated2011-02-07
Date Terminated2011-09-23
Product Quantity57,252 wipes
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.
Firm 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.
Root Cause
Material/Component Contamination
Distribution Pattern
Worldwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.