Device recall

Z-2209-2013: Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011…

FDA device recall · Class II · Cincinnati Sub-Zero Products Inc

Key facts

Recall number (Z-number) Z-2209-2013
Recall event 66155
Product Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-Hypothermia device used to lower or to raise a patients temperature and/or maintain a desired patient temperature through conductive heat transfer.
Product code DWJ
Recalling firm Cincinnati Sub-Zero Products Inc
Recall class Class II
Status Terminated
Termination date Aug 22, 2014
510(k) numbers K101589
FEI number 1516825

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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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