FDA (Devices) recall action 71966

Halyard Health, Inc recalled 32 products on 2015-09-09

The FDA (Devices) publishes a recall like this one as 32 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 32 pages.

Products: 32
Announced: 2015-09-09
Critical: 0
Units: 19,250

Why these products were recalled

The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–25 of 32

HighFDA (Devices)··2015-09-09
Halyard Recalls KimVent Closed Suction Systems Due to Valve Malfunction
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, compromising the closed system.
Product
KimVent* Closed Suction System for Adults, 14 F, D-Tip, T-Piece (Product Code 22059); KimVent* Closed Suction System for Adults, 14 F, T-Piece, Directional Tip (Product Code 8155) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit fo
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Halyard KimVent Closed Suction System Thumb Valve Recall
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, even when it appears locked.
Product
KimVent* Closed Suction System for Adults, 14 F, Elbow, D-Tip (Product Code 2219) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
Category
Distribution
1 state
SevereFDA (Devices)··2015-09-09
Halyard KimVent Closed Suction System Thumb Valve Recall
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, despite appearing locked.
Product
KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DT, T-Piece (Product Code 220569) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Halyard KimVent Closed Suction System Recalled Due to Valve Malfunction
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, potentially compromising airway protection.
Product
KimVent* Closed Suction System for Adults, 14 F, T-Piece, MDI (Product Code 8308) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Halyard Health Recalls KimVent Closed Suction Systems Due to Valve Defect
Halyard Health is recalling KimVent Closed Suction Systems for neonates and pediatrics because the thumb valve may remain partially open after suctioning, despite appearing closed.
Product
KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Manifold (Product Code 201) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Halyard Recalls KimVent Closed Suction Systems Due to Valve Defect
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after use, potentially compromising the closed system.
Product
KimVent* Closed Suction System for Adults, 12 F, T-Piece (Product Code 2155); KimVent* Closed Suction System for Adults, 14 F, T-Piece (Product Code 2205, 8169, 8248, 22015, 22025, 220125, 220135) A tracheobronchial suction catheter is a device that is attached to a port of t
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Halyard KimVent Closed Suction System Thumb Valve Recall
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, even when it appears locked.
Product
KimVent* Closed Suction System for Adults, 14 F, DSE (Product Code 2210); KimVent* Closed Suction System for Adults, 12 F, DSE (Product 21603); KimVent* Closed Suction System for Adults, 14 F, DSE (Product Code 22103); KimVent* Closed Suction System for Adults, 14 F, DSE (Product
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Halyard KimVent Closed Suction Systems Recalled Due to Valve Defect
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, even when it appears locked.
Product
KimVent* Closed Suction Systems for Adults, 14 F, Qwik Clip (Product Code 2273) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Halyard KimVent Closed Suction System Thumb Valve Recall
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, despite appearing closed.
Product
KimVent* Closed Suction System for Adults, 14 F, DSE, DT (Product Code 22109) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Halyard KimVent Closed Suction System Thumb Valve Recall
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, potentially compromising the closed system.
Product
KimVent* Turbo-Cleaning Closed Suction System for Adults, 10 F, T-Piece (Product Code 227105) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Halyard Health Recalls NovaPlus Trach Care Closed Suction Systems
Halyard Health is recalling specific NovaPlus Trach Care Closed Suction Systems because the thumb valve may remain partially open after suctioning, potentially compromising airway safety.
Product
NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, Directional Tip, 14F (Product Code 2V22109) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a pat
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Halyard KimVent Pediatric Closed Suction System Thumb Valve Defect Recall
Halyard Health is recalling KimVent Wet Pak Closed Suction Systems for pediatrics because the thumb valve may remain partially open after use, potentially compromising airway safety.
Product
KimVent* Wet Pak* Closed Suction System for Pediatrics, 10 F, Y Adapter (Product Code 8281) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Halyard KimVent Closed Suction System Thumb Valve Recall
Halyard Health is recalling KimVent Turbo-Cleaning Closed Suction Systems because the thumb valve may remain partially open after suctioning, potentially compromising the closed system.
Product
KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece (Product Code 22705); KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece (Product Code 2270135) A tracheobronchial suction catheter is a device that is attached to a port of the airway
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Halyard KimVent Closed Suction System Thumb Valve Recall
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, potentially compromising the closed system.
Product
KimVent* Closed Suction System for Adults, 12 F, T-Piece,12 in Tracheostomy (Product Code 215135); KimVent* Closed Suction System for Adults, 12 F, T-Piece, 12 in Trach (Product Code 21513511) A tracheobronchial suction catheter is a device that is attached to a port of the air
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Halyard KimVent Closed Suction System Recalled Due to Valve Malfunction
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, compromising the closed system.
Product
KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 2271418) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Halyard KimVent Closed Suction System Thumb Valve Recall
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, even when it appears locked.
Product
KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE (Product Code 227); KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE (Product Code 22703); KimVent* Turbo-Cleaning Closed Suction System for Adults, 12 F, DSE (Product Code 22716) A tracheobro
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Halyard Recalls KimVent Closed Suction Systems Due to Valve Malfunction
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, potentially compromising the closed system.
Product
KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE, MDI (Product 8224); KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE (Product Code 22106); KimVent* Closed Suction System for Adults, 14 F, DSE, Wet Pak (Produce Code 221036) A tracheobronchial suction c
Category
Distribution
1 state
SevereFDA (Devices)··2015-09-09
Halyard Health Recalls KimVent Multi-Access Port Replacement Catheters
Halyard Health is recalling KimVent Multi-Access Port Replacement Catheters because the thumb valve may remain partially open after suctioning, potentially compromising the closed suction system.
Product
KimVent* Multi-Access Port Replacement Catheter for Adults,Tracheostomy, 14 F (Product Code 2401453-5) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airw
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Halyard KimVent Closed Suction System Recall for Valve Defect
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, even when it appears locked.
Product
KimVent* Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 22108); KimVent* Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 221038) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to a
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Halyard Recalls KimVent Closed Suction Systems Due to Valve Malfunction
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, despite appearing locked.
Product
KimVent* Closed Suction System for Adults, 14 F, MDI, T-Piece, 12 in Tracheostomy (Product Code 2201358); KimVent* Closed Suction System for Adults, 14 F, MDI, T-Piece (Produce Code 2201258) A tracheobronchial suction catheter is a device that is attached to a port of the airway
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Halyard NovaPlus Trach Care Closed Suction System Thumb Valve Recall
Halyard Health is recalling NovaPlus Trach Care Closed Suction Systems because the thumb valve may remain partially open after suctioning, potentially compromising the closed system.
Product
NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, 14F (Product Code 2V2210) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airwa
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Halyard Health Recalls NovaPlus Trach Care Closed Suction Systems
Halyard Health is recalling specific NovaPlus Trach Care Closed Suction Systems because the thumb valve may remain partially open after use, potentially compromising airway protection.
Product
NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, Directional Tip, 14F (Product Code 2V22059) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Halyard Recalls KimVent Closed Suction Systems Due to Valve Malfunction
Halyard Health is recalling KimVent Closed Suction Systems for neonates and pediatrics because the thumb valve may remain partially open after suctioning.
Product
KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Y-Adapter (Product Code 195); KimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Y-Adapter (Product Code 196); KimVent* Closed Suction System for Neonates/Pediatrics, 7 F, Y-Adapter (Product Code 197); KimVent
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Halyard Health Recalls NovaPlus Trach Care Closed Suction Systems
Halyard Health is recalling specific NovaPlus Trach Care Closed Suction Systems because the thumb valve may remain partially open after suctioning, potentially compromising airway protection.
Product
NovaPlus Trach Care* Closed Suction System for Adults, Clear T-Piece MDI Adapter, 14F (Product Code 2V220158) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's u
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Halyard KimVent Closed Suction System Thumb Valve Recall
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, despite appearing closed.
Product
KimVent* Closed Suction System for Adults, 12 F, Elbow (Product Code 216); KimVent* Closed Suction KimVent* Closed Suction System for Adults, 14 F, Elbow (Product Code 221); KimVent* Closed Suction System for Adults, 14 F, Elbow (Product Code 22113) A tracheobronchial suction c
Category
Distribution
1 state