Device recall

Z-0781-2010: FilteredFlo Cardiac Blanket. The device is used to distribute heated air around…

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

Key facts

Recall number (Z-number) Z-0781-2010
Recall event 53947
Product FilteredFlo Cardiac Blanket. The device is used to distribute heated air around a patient (for patient warming).
Product code DWJ
Recalling firm Cincinnati Sub-Zero Products Inc
Recall class Class II
Status Terminated
Termination date Jan 25, 2012
510(k) numbers K942599
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

Browse all FDA device recalls (products)