Z-0963-2014Class I

ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 9.0, Rx only

Name: Z-0963-2014 ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 9.0, Rx only
Creator: Teleflex Medical
Published: 2014-01-06
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2014-01-06 / Terminated

FDA source

Teleflex Medical began a recall of 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... on 2014-01-06. FDA classified it as Class I and gives the reason as "The tracheal tube can kink during patient use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0963-2014
Classification: Class I
Status: Terminated
Initiated: 2014-01-06
Posted: 2014-02-21
Terminated: 2016-06-17
Recalling firm: Teleflex Medical
Product: 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.
Product code: BTR Tube, Tracheal (W/Wo Connector)
Reason for recall: The tracheal tube can kink during patient use.
FDA root cause: Other
Action: Teleflex Medical sent an Urgent Medical Device Recall Notification letter dated January 6, 2014, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to immediately discontinue use and quarantine any affected product. Return the product by completing the enclosed Recall Ackknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service to receive a Return Goods Authorization (RGA) number and instructions for the return of the affected product to Teleflex Medical. Consignees with no affected stock, should also complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881. Consignees with questions were instructed to call 1-866-246-6990. For questions regarding this recall call 919-572-8014.
Quantity in commerce: 190,871 each (148, 275 US)
Distribution: 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.
Product codes and lots: Product Code: 5-14018, Lot numbers: 01B1200213 and 01B1200336.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0963-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0950-2014	Class I	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-21
Z-0951-2014	Class I	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-21
Z-0952-2014	Class I	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-21
Z-0953-2014	Class I	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-21
Z-0954-2014	Class I	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-21
Z-0955-2014	Class I	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-21
Z-0956-2014	Class I	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-21
Z-0957-2014	Class I	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-21
Z-0958-2014	Class I	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-21
Z-0959-2014	Class I	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-21
Z-0960-2014	Class I	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-21
Z-0961-2014	Class I	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-21
Z-0962-2014	Class I	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-21
Z-0963-2014	Class I	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-21

Product code BTR

K091761Class IITeleflex Isis Hvt Tracheal Tube, Cuffed, with Subglottic Secretion Suction PortTeleflexmedical, Inc. / cleared 2009-10-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)