Sybaritic, Inc., SlimLine Health Environment Capsule, a dry heat body chamber with facial and body chamber LED panels.
- Company
- Sybaritic, Inc
- Recall Initiated
- June 18, 2008
- Posted
- June 23, 2009
- Terminated
- July 6, 2012
- Recall Number
- Z-1423-2009
- Quantity
- 1
- Firm Location
- Bloomington, MN
Reason for Recall
Misbranded and sale without pre-market notification.
Distribution
UT
Lot / Code Info
Serial Number 2109257
Root Cause
PMA
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.
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