RecallDepth

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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