Device recall

Z-0714-06: Blue Line Ultra Tracheostomy Tube 8.00mm Inner Cannula REF 100/858/080

FDA device recall · Class III · Smiths Medical ASD, Inc.

Key facts

Recall number (Z-number) Z-0714-06
Recall event 34762
Product Blue Line Ultra Tracheostomy Tube 8.00mm Inner Cannula REF 100/858/080
Product code BTO
Recalling firm Smiths Medical ASD, Inc.
Recall class Class III
Status Terminated
Termination date May 8, 2012
510(k) numbers K030381
FEI number 1217052

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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