RecallRadar

FDA Device recall Z-0956-2014

ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 9.0, 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, 9.0, 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-0956-2014
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, 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.

Reason

The tracheal tube can kink during patient use.

Identifiers

code_info
Product Code: 5-13018, Lot numbers: 01A1000435, 01D1000122, 01G1000099, 01J1000398, 01A1100276, 01A1100516, 01B1100012,…Product Code: 5-13018, Lot numbers: 01A1000435, 01D1000122, 01G1000099, 01J1000398, 01A1100276, 01A1100516, 01B1100012, 01F1100336, 01C1100113, 01A1200212, 01G1200208, 01G1100440 and 01D1100342

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-0956-2014%22

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