Inter x 5002 Device, Inter x Professional Sport Device, Inter x 1000 Personal Device, and Inter x Personal Sport package
FDA device recall Z-2105-2011 · posted 2011-04-28 · Terminated
Recall details
- Recalling firm
- Neuro Resource Group Inc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- GZJ
- Quantity affected
- 57,252 wipes
- Distribution
- Worldwide Distribution
- Date initiated
- 2011-02-07
- Date posted
- 2011-04-28
- Date terminated
- 2011-09-23
- Location
- Plano, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTERX5000 (K042912) | Neuro Resource Group, Inc. | 2005-05-17 |