RecallRadar

FDA Device recall Z-0950-2014

ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.0, 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, 6.0, 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-0950-2014
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, 6.0, 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: 5-13012, Lot numbers: 01A1000055, 01B1000254, 01G1000275, 01J1000399, 01M1000285, 01A1100083, 01A1100448,…Product Code: 5-13012, Lot numbers: 01A1000055, 01B1000254, 01G1000275, 01J1000399, 01M1000285, 01A1100083, 01A1100448, 01E1100345, 01G1100116, 01B1100212, 01D1100297, 01C1200082, 01F1200369, 01E1200460, 01F1100482, 01F1200401, 01F1300054, 01H1200296, 01H1100157, 01E1300295 and 01F1300176.

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-0950-2014%22

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