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Terminated

Sybaritic, Inc., SlimLine Health Environment Capsule, a dry heat body chamber with facial and body chamber LED panels.

FDA Recall Z-1423-2009 · Posted 2009-06-23

Recalling FirmSybaritic, Inc
Recall StatusTerminated
Product CodeISA
Date Initiated2008-06-18
Date Terminated2012-07-06
Product Quantity1

Reason for Recall

Misbranded and sale without pre-market notification.

Firm Action

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

Distribution Pattern

UT

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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