Sybaritic, Inc., SlimLine Health Environment Capsule, a dry heat body chamber with facial and body chamber LED panels.
FDA device recall Z-1423-2009 · posted 2009-06-23 · Terminated
Recall details
- Recalling firm
- Sybaritic, Inc
- Reason for recall
- Misbranded and sale without pre-market notification.
- Action taken
- Sybaritic sent a letter to the consignee on June 18, 2008. The letter confirmed their phone conversation on June 16 regarding the required Field Correction of the device. The letter also described the changes to be performed by the local technician to be in compliance with the FDA.
- Root cause
- PMA
- Status
- Terminated
- Product code
- ISA
- Quantity affected
- 1
- Distribution
- UT
- Date initiated
- 2008-06-18
- Date posted
- 2009-06-23
- Date terminated
- 2012-07-06
- Location
- Bloomington, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.