Device recall

Z-0667-2007: Disposable components of the superDimension Bronchus System: Locatable Guide Kit…

FDA device recall · Class II · SuperDimension, Inc.

Key facts

Recall number (Z-number) Z-0667-2007
Recall event 36947
Product Disposable components of the superDimension Bronchus System: Locatable Guide Kit (AKI00017-01) and Extended Working Channel (AKI00041-01).
Product code JAK
Recalling firm SuperDimension, Inc.
Recall class Class II
Status Terminated
Termination date Nov 20, 2008
FEI number 3004962788

At a glance

  • None 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

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