RecallRadar

FDA Device recall Z-0953-2014

ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.5, 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, 7.5, 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-0953-2014
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, 7.5, 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: 5-13015, Lot numbers: 01A1000503, 01A1000056, 01B1000243, 01B1000023, 01B1000257, 01E1000404, 01E1000528,…Product Code: 5-13015, Lot numbers: 01A1000503, 01A1000056, 01B1000243, 01B1000023, 01B1000257, 01E1000404, 01E1000528, 01F1000093, 01G1000243, 01J1000253, 01G1000430, 01M1000283, 01M1000288, 01B1100010, 01C1100226, 01C1100151, 01C1100374, 01E1100100, 01E1100347, 01D1100358, 01C1100488, 01H1100354, 01E1100251, 01B1100463, 01J1100233, 01A1200448, 01C1200084, 01C1200384, 01B1200546, 01C1200467, 01K1100239, 01M1100365, 01E1200319, 01J1100379, 01H1200042, 01F1200035, 01E1200547, 01L1100370, 01J1200073, 01J1200198, 01E1300294, 01E1300322, 01E1300430, 01G1300424, 01G1300095 and 01H1300325, 01J1300002.

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-0953-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.