Device recall

Z-1039-03: Lo-Profile Fenestrated Tracheostomy Tube, Cuffed and Fenestrated Tube I.D. 9.0mm…

FDA device recall · Class III · Portex Inc.

Key facts

Recall number (Z-number) Z-1039-03
Recall event 26621
Product Lo-Profile Fenestrated Tracheostomy Tube, Cuffed and Fenestrated Tube I.D. 9.0mm Catalog Number: 593090
Product code BTO
Recalling firm Portex Inc.
Recall class Class III
Status Terminated
Termination date Mar 31, 2004
510(k) numbers K922749
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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