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TELEFLEX LLC

FDA Regulatory Profile

Summary

Total Recalls
150 (130 Class I)
510(k) Clearances
10
Inspections
9
Compliance Actions
0

Known Names

teleflex, teleflex medical

Recent Recalls

NumberClassProductDate
Z-1963-2023Class IEndotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080080May 25, 2023
Z-1904-2023Class ISlick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150040May 25, 2023
Z-1889-2023Class IEndotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082075May 25, 2023
Z-1841-2023Class ISlick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170140May 25, 2023
Z-1962-2023Class IEndotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080075May 25, 2023
Z-1866-2023Class IPreformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180055May 25, 2023
Z-1882-2023Class IEndotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080095May 25, 2023
Z-1863-2023Class IPreformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180040May 25, 2023
Z-1950-2023Class IPreformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780090May 25, 2023
Z-1865-2023Class IPreformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180050May 25, 2023
Z-1874-2023Class IEndotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382030May 25, 2023
Z-1879-2023Class IPreformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781045May 25, 2023
Z-1861-2023Class IPreformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180030May 25, 2023
Z-1929-2023Class IEndotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380045May 25, 2023
Z-1927-2023Class IEndotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380035May 25, 2023
Z-1877-2023Class IPreformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780075May 25, 2023
Z-1834-2023Class ISlick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170085May 25, 2023
Z-1867-2023Class IPreformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180060May 25, 2023
Z-1945-2023Class IPreformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780060May 25, 2023
Z-1961-2023Class IEndotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080070May 25, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K153652ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/SetJune 21, 2016
K140110FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SETMarch 27, 2015
K141940CONCHASMART COLUMNNovember 24, 2014
K140556CONCHASMART BREATHING CIRCUITSeptember 24, 2014
K131912CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMNMarch 6, 2014
K123974PERCUTANEOUS INTRODUCER KITFebruary 21, 2013
K121403CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SETJune 20, 2012
K103658FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTERMay 16, 2012
K861951MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETERJune 19, 1986
K860307PEEL AWAY & SPLIT SHEATH PERCU CATH INTRODUCER SETMay 20, 1986