Device recall

Z-0882-2011: Air bubble detect module, catalog 802110, Terumo Cardiovascular System Corp, Ann…

FDA device recall · Class II · Terumo Cardiovascular Systems Corporation

Key facts

Recall number (Z-number) Z-0882-2011
Recall event 57416
Product Air bubble detect module, catalog 802110, Terumo Cardiovascular System Corp, Ann Arbor, MI. The air bubble detect module is used with an air sensor to detect gross air bubbles in the perfusion circuit.
Product code DTQ
Recalling firm Terumo Cardiovascular Systems Corporation
Recall class Class II
Status Terminated
Termination date Apr 17, 2012
510(k) numbers K022947
FEI number 1828100

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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)