CLASS I Device recall · Reported 5 Mar 2014 · FDA Enforcement Report

ISIS HVT Tracheal Tube Cuffed recalled by Teleflex Medical

Teleflex Medical is recalling ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, distributed nationwide in the US. The recall was initiated on 6 Jan 2014 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesProduct Code: 5-14018, Lot numbers: 01B1200213 and 01B1200336.

Quantity recalled190,871 each (148, 275 US)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0963-2014
FDA event ID: 67266
Recalling firm: Teleflex Medical, Research Triangle Park, NC
Classification: Class I
Status: Terminated
Recall initiated: 6 Jan 2014
FDA classified: 21 Feb 2014
Reported: 5 Mar 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

6 Jan 2014	Recall initiated by company
21 Feb 2014	Classified by FDA	+46 days
5 Mar 2014	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The tracheal tube can kink during patient use.

Product as listed by the FDA

ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 9.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.

Where it was distributed

Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

The tracheal tube can kink during patient use.

Which lots are affected?

Product Code: 5-14018, Lot numbers: 01B1200213 and 01B1200336.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

13 other products · FDA event 67266

This product is part of a recall event; the main page for the event is ISIS HVT Tracheal Tube Cuffed recalled by Teleflex Medical.

Reported	Class	Recall	Company	Reason	Where
5 Mar 2014	CLASS I	ISIS HVT Tracheal Tube Cuffed recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
5 Mar 2014	CLASS I	ISIS HVT Tracheal Tube Cuffed recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
5 Mar 2014	CLASS I	ISIS HVT Tracheal Tube Cuffed recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
5 Mar 2014	CLASS I	ISIS HVT Tracheal Tube Cuffed recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
5 Mar 2014	CLASS I	ISIS HVT Tracheal Tube Cuffed recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
5 Mar 2014	CLASS I	ISIS HVT Tracheal Tube Cuffed recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
5 Mar 2014	CLASS I	ISIS HVT Tracheal Tube Cuffed recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
5 Mar 2014	CLASS I	ISIS HVT Tracheal Tube Cuffed recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
5 Mar 2014	CLASS I	ISIS HVT Tracheal Tube Cuffed recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
5 Mar 2014	CLASS I	ISIS HVT Tracheal Tube Cuffed recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
5 Mar 2014	CLASS I	ISIS HVT Tracheal Tube Cuffed recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
5 Mar 2014	CLASS I	ISIS HVT Tracheal Tube Cuffed recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
5 Mar 2014	CLASS I	ISIS HVT Tracheal Tube Cuffed recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide

More recalls from Teleflex Medical

All 235

Reported	Class	Recall	Company	Reason	Where
1 Jun 2022Device	CLASS II	Teleflex Flex tube, Product #20011, sterile recalled by Teleflex Medical	Teleflex Medical	Sterility	Nationwide
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23 Feb 2022Device	CLASS I	Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
23 Feb 2022Device	CLASS I	Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
23 Feb 2022Device	CLASS I	Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device) recalled	Teleflex Medical	Other	Nationwide

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All 13,778

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