RecallRadar

FDA Device recall Z-0951-2014

ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.5, 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, 6.5, 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-0951-2014
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, 6.5, 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: 5-13013, Lot numbers: 01A1000316, 01B1000255, 01J1000392, 01A1100209, 01M1000286, 01C1100125, 01D1100298,…Product Code: 5-13013, Lot numbers: 01A1000316, 01B1000255, 01J1000392, 01A1100209, 01M1000286, 01C1100125, 01D1100298, 01F1100648, 01H1100367, 01L1100147, 01J1100232, 01L1100371, 01M1100176, 01C1200083, 01E1200461, 01E1200545, 01H1200156, 01F1200171, 01A1300637, 01F1300055 and 01F1300297.

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-0951-2014%22

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