The Recall Desk

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

26–32 of 32

  • HighFDA (Devices)··2015-09-09

    Halyard KimVent Closed Suction Systems 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 the closed system.

    Product
    KimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Elbow (Product Code 206); KimVent* Closed Suction System for Neonates/Pediatrics, 8 F, Elbow (Product Code 208); KimVent* Closed Suction System for Pediatrics, 10 F, Elbow (Product Code 210); KimVent* Closed Suction Sys
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2015-09-09

    Halyard Health Recalls KimVent Closed Suction Systems Due to Valve Defect

    Halyard Health is recalling specific KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, compromising the device's intended function.

    Product
    KimVent* Wet Pak* Closed Suction System for Adults, 14 F, T-Piece (Product Code 22056); KimVent* Wet Pak* Closed Suction System for Adults, 16 F, T-Piece (Product Code 22556); KimVent* Wet Pak* Closed Suction System for Adults, 14 F, T-Piece (Product Code 22012356) A tracheobron
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2015-09-09

    Halyard Recalls NovaPlus Trach Care Closed Suction Systems Due to Valve Defect

    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, T-Piece, 14F (Product Code 2V220135); NovaPlus Trach Care* Closed Suction System for Adults, Clear T-Piece, 14F (Product Code 2V2205) A tracheobronchial suction catheter is a device that is attached to a port of the airway c
    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* Wet Pak* Closed Suction System for Adults, 14 F, Elbow (Product Code 2276); KimVent* Wet Pak* Closed Suction System for Adults, 14 F, Elbow (Product Code 22169) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as n
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2015-09-09

    Halyard KimVent Closed Suction System Thumb Valve Recall

    Halyard Health is recalling KimVent Multi-Access Port Closed Suction Systems because the thumb valve may remain partially open after suctioning, despite appearing closed.

    Product
    KimVent* Multi-Access Port Closed Suction System for Adults, Endotracheal, DSY, 14 F (Product Code 24014-5) 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
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2015-09-09

    Halyard KimVent Suction Catheter Thumb Valve Recall

    Halyard Health is recalling KimVent Multi-Access Port Replacement Catheters because the thumb valve may remain partially open after suctioning, compromising the closed suction system.

    Product
    KimVent* Multi-Access Port Replacement Catheter for Adults, Endotracheal,16 F (Product Code 240165-5) 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 air
    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 because the thumb valve may remain partially open after suctioning, potentially compromising the closed system.

    Product
    KimVent* Multi-Access Port Closed Suction System for Adults,Tracheostomy, DSY, MDI, 14 F (Product Code 240438-5) 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
    Category
    Distribution
    1 state