Recall Z-2105-2011 ยท GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Neuro Resource Group Inc
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.
| Date | Apr 28, 2011 (initiated Feb 7, 2011) |
| Status | Terminated |
| Reason | Product package contains alcohol prep pads recalled by Triad Group because the prep pads have the potential to be contaminated with an objectionable organism. |
| Root cause | 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 | 57,252 wipes |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042912 | INTERX5000 Neuro Resource Group, Inc., May 17, 2005 |