Device recall

Z-2010-2009: Transtracheal (Jet Ventilation) Catheter ACU 1060.1, labeled sterile if…

FDA device recall · Class II · Instrumentation Industries Inc

Key facts

Recall number (Z-number) Z-2010-2009
Recall event 52898
Product Transtracheal (Jet Ventilation) Catheter ACU 1060.1, labeled sterile if unopened. The Jet Ventilation Catheter allows a safe and atraumatic transtracheal access for oxygenation/ventilation.
Product code BTO
Recalling firm Instrumentation Industries Inc
Recall class Class II
Status Terminated
Termination date Oct 15, 2009
510(k) numbers K955461
FEI number 2518436

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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