Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2105-2011

Inter x 5002 Device, Inter x Professional Sport Device, Inter x 1000 Personal Device, and Inter x Personal...

InterX Technologies / initiated 2011-02-07 / Terminated / root cause: manufacturing process

Neuro Resource Group Inc began a recall of 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... on . The reason FDA records is "Product package contains alcohol prep pads recalled by Triad Group because the prep pads have the potential to be contaminated with an objectionable organism". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2105-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
InterX Technologies
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.
Product code
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
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.
Root cause tag
manufacturing process
FDA 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 in commerce
57,252 wipes
Distribution
Worldwide Distribution
Product codes and lots
All lots of the alcohol wipes.