FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2105-2011
- Recalling firm
- Neuro Resource Group Inc
- 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.
- Status
- Terminated
- Initiated
- 2011-02-07
- Posted
- 2011-04-28
- Terminated
- 2011-09-23
- 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
- Lot, serial or model codes
- All lots of the alcohol wipes.
- 510(k) numbers
- ["K042912"]
- PMA numbers
- not on file
- Product code
- GZJ
- Firm FEI
- 3004786509
- Firm city
- Plano
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28