RecallRadar

FDA Device recall Z-0954-2014

ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.0, Rx only, Product Usage: A tracheal tube is a device inserted int…

On 2014-03-05 the FDA classified a Class I recall of ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.0, Rx only, Product Usage: A tracheal tube is a device inserted int… by Teleflex Medical, citing the tracheal tube can kink during patient use.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0954-2014
ClassificationClass I
Statusterminated
Initiated2014-01-06
Published2014-03-05
Last updated2026-09-13 11:53 UTC
CompanyTeleflex Medical
DistributionUS

Product

ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.0, 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.

Reason

The tracheal tube can kink during patient use.

Identifiers

code_info
Product Code: 5-13016, Lot numbers: 01A1000317, 01C1000059, 01D1000386, 01D1000112, 01G1000245, 01J1000396, 01M1000284,…Product Code: 5-13016, Lot numbers: 01A1000317, 01C1000059, 01D1000386, 01D1000112, 01G1000245, 01J1000396, 01M1000284, 01B1100011, 01B1100070, 01C1100114, 01C1100529, 01E1100227, 01C1100606, 01B1100505, 01B1100248, 01H1100103, 01A1200116, 01B1200547, 01B1200422, 01E1100492, 01C1200085, 01C1200385, 01D1100348, 01D1200270, 01D1200087, 01G1100117, 01E1200562, 01G1200079, 01C1300339, 01C1300437, 01D1300076, 01E1300297, 01D1300194 and 01E1300061.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0954-2014%22

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