Device recall

Z-1605-2009: DERMALIFE Takara. Part #E30006-02 - Takara; Renew 2G, w/Pedestal. This is the…

FDA device recall · Class II · Sybaritic, Inc

Key facts

Recall number (Z-number) Z-1605-2009
Recall event 52036
Product DERMALIFE Takara. Part #E30006-02 - Takara; Renew 2G, w/Pedestal. This is the Spa Jet product re-named for Takara Belmont, our New Jersey based distributor, identical to Part #E30006-01 other than the stickers on the unit.
Product code IMB
Recalling firm Sybaritic, Inc
Recall class Class II
Status Terminated
Termination date Jul 5, 2012
510(k) numbers K003916
FEI number 2131125

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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