Halyard Health recalls
Halyard Health appears in 57 official U.S. recall notices indexed by RecallRadar, most recently on 2018-04-25.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 57 |
|---|---|
| Published | 2014-12-31 to 2018-04-25 |
| By agency | FDA Device (57) |
| By classification | Class II (52), Class I (5) |
| By status | terminated (57) |
| Distribution named in notices | AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, US, UT, VA, WA, WV |
Recalls
- Halyard Closed Suction System for Adults, Multi-Access¿Port¿Closed¿Suction¿System¿for¿Adults
FDA Device · Class II · 2018-04-25 · Halyard Health
Reason: Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use. - Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway
FDA Device · Class II · 2018-04-25 · Halyard Health
Reason: Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use. - Halyard Closed Suction System for Adults, Turbo- cleaning¿Closed¿Suction¿System¿for¿Adults,¿Double¿Swivel¿Elbow (DSE). Used to aspirate liq…
FDA Device · Class II · 2018-04-25 · Halyard Health
Reason: Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use. - CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagnetic Transmitting Stylet and CORFLO* Enteral Feeding tube, ANTI…
FDA Device · Class II · 2018-04-11 · Halyard Health
Reason: The transmitting stylet within CORTRAK* 2 nasogastric/Nasointestinal (NG/NI) Feeding Tubes with ANTI-IV* connector (Product Code 20-9551Trak2A) may be visible within the window of the exit port of the feeding tube. Base… - NOVAPLUS* Endotracheal WET PAK* Closed Suction System for Adults with BALLARD* Technology, Double Swivel Elbow, 14 F. 6 vials per kit, 20 k…
FDA Device · Class II · 2017-11-29 · Halyard Health
Reason: Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents. - Halyard Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 or 6 vials per kit, 20 kits per case
FDA Device · Class II · 2017-11-29 · Halyard Health
Reason: Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents. - Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece, Wet Pak. 12 vials per kit, 20 kits per case
FDA Device · Class II · 2017-11-29 · Halyard Health
Reason: Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents. - Halyard Closed Suction System for Adults, 14 F, Elbow, Directional Tip, Wet Pak. 12 vials per kit, 20 kits per case
FDA Device · Class II · 2017-11-29 · Halyard Health
Reason: Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents. - Halyard Closed Suction System for Adults, 14 F, T-Piece, Wet Pak. 12 or 6 vials per kit, 20 kits per case
FDA Device · Class II · 2017-11-29 · Halyard Health
Reason: Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents. - Halyard Closed Suction System for Adults with BALLARD Technology WET PAK. 12 saline vials per kit, 20 kits per case
FDA Device · Class II · 2017-11-29 · Halyard Health
Reason: Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents. - Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI, Wet Pak. 12 vials per kit, 20 kits per case
FDA Device · Class II · 2017-11-29 · Halyard Health
Reason: Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents. - Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 saline vials per kit, 20 kits per case
FDA Device · Class II · 2017-11-29 · Halyard Health
Reason: Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents. - Halyard Closed Suction System for Adults, 14 F, T-Piece, MDI, Wet Pak. 12 vials per kit, 20 kits per case
FDA Device · Class II · 2017-11-29 · Halyard Health
Reason: Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents. - Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile
FDA Device · Class II · 2016-12-21 · Halyard Health
Reason: Defects: Product may be discolored and brittle resulting in the inability of the user to don the gloves without tearing. - Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Product Code 44965 NS
FDA Device · Class II · 2016-12-14 · Halyard Health
Reason: Drapes within the affected lots may include a manufacturing variation that prevents convenient removal of the coated release paper, which inhibits easy access to the surgical site. - Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504)
FDA Device · Class II · 2016-08-17 · Halyard Health
Reason: Mismatch between the length of the RF electrode (probe) and the cannula (introducer), - KimVent* Turbo-Cleaning Closed Suction System for Adults, 10 F, T-Piece (Product Code 227105) A tracheobronchial suction catheter is a devi…
FDA Device · Class II · 2015-09-09 · Halyard Health
Reason: 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. - NovaPlus Trach Care* Closed Suction System for Adults, Clear T-Piece MDI Adapter, 14F (Product Code 2V220158) A tracheobronchial suction…
FDA Device · Class II · 2015-09-09 · Halyard Health
Reason: 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. - KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 2271418) A tracheobronchial suction catheter is a de…
FDA Device · Class II · 2015-09-09 · Halyard Health
Reason: 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. - KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DT, T-Piece (Product Code 220569) A tracheobronchial suction catheter is a device…
FDA Device · Class II · 2015-09-09 · Halyard Health
Reason: 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. - KimVent* Wet Pak* Closed Suction System for Adults, 14 F, T-Piece (Product Code 22056)
FDA Device · Class II · 2015-09-09 · Halyard Health
Reason: 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. - KimVent* Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 22108)
FDA Device · Class II · 2015-09-09 · Halyard Health
Reason: 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. - KimVent* Multi-Access Port Replacement Catheter for Adults, Endotracheal,16 F (Product Code 240165-5) A tracheobronchial suction catheter i…
FDA Device · Class II · 2015-09-09 · Halyard Health
Reason: 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. - KimVent* Closed Suction System for Adults, 14 F, T-Piece, MDI (Product Code 8308) A tracheobronchial suction catheter is a device that is a…
FDA Device · Class II · 2015-09-09 · Halyard Health
Reason: 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. - KimVent* Closed Suction System for Adults, 14 F, D-Tip, T-Piece (Product Code 22059)
FDA Device · Class II · 2015-09-09 · Halyard Health
Reason: 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. - KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Manifold (Product Code 201) A tracheobronchial suction catheter is a device th…
FDA Device · Class II · 2015-09-09 · Halyard Health
Reason: 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. - KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece (Product Code 22705)
FDA Device · Class II · 2015-09-09 · Halyard Health
Reason: 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. - KimVent* Closed Suction System for Adults, 14 F, DSE, DT (Product Code 22109) A tracheobronchial suction catheter is a device that is attac…
FDA Device · Class II · 2015-09-09 · Halyard Health
Reason: 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. - KimVent* Closed Suction System for Adults, 14 F, MDI, T-Piece, 12 in Tracheostomy (Product Code 2201358)
FDA Device · Class II · 2015-09-09 · Halyard Health
Reason: 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. - NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, Directional Tip, 14F (Product Code 2V22109) A tracheobronchial…
FDA Device · Class II · 2015-09-09 · Halyard Health
Reason: 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. - KimVent* Closed Suction Systems for Adults, 14 F, Qwik Clip (Product Code 2273) A tracheobronchial suction catheter is a device that is att…
FDA Device · Class II · 2015-09-09 · Halyard Health
Reason: 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. - KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE (Product Code 227)
FDA Device · Class II · 2015-09-09 · Halyard Health
Reason: 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. - NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, Directional Tip, 14F (Product Code 2V22059) A tracheobronchial suction cath…
FDA Device · Class II · 2015-09-09 · Halyard Health
Reason: 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. - KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE, MDI (Product 8224)
FDA Device · Class II · 2015-09-09 · Halyard Health
Reason: 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. - KimVent* Closed Suction System for Adults, 14 F, DSE (Product Code 2210)
FDA Device · Class II · 2015-09-09 · Halyard Health
Reason: 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. - KimVent* Closed Suction System for Adults, 12 F, T-Piece (Product Code 2155)
FDA Device · Class II · 2015-09-09 · Halyard Health
Reason: 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. - KimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Elbow (Product Code 206)
FDA Device · Class II · 2015-09-09 · Halyard Health
Reason: 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. - KimVent* Closed Suction System for Adults, 14 F, Elbow, D-Tip (Product Code 2219) A tracheobronchial suction catheter is a device that is a…
FDA Device · Class II · 2015-09-09 · Halyard Health
Reason: 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. - KimVent* Closed Suction System for Adults, 12 F, Elbow (Product Code 216)
FDA Device · Class II · 2015-09-09 · Halyard Health
Reason: 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. - KimVent* Multi-Access Port Replacement Catheter for Adults,Tracheostomy, 14 F (Product Code 2401453-5) A tracheobronchial suction catheter…
FDA Device · Class II · 2015-09-09 · Halyard Health
Reason: 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. - KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Y-Adapter (Product Code 195)
FDA Device · Class II · 2015-09-09 · Halyard Health
Reason: 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. - KimVent* Closed Suction System for Adults, 12 F, T-Piece,12 in Tracheostomy (Product Code 215135)
FDA Device · Class II · 2015-09-09 · Halyard Health
Reason: 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. - KimVent* Wet Pak* Closed Suction System for Adults, 14 F, Elbow (Product Code 2276)
FDA Device · Class II · 2015-09-09 · Halyard Health
Reason: 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. - NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, 14F (Product Code 2V220135)
FDA Device · Class II · 2015-09-09 · Halyard Health
Reason: 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. - KimVent* Multi-Access Port Closed Suction System for Adults,Tracheostomy, DSY, MDI, 14 F (Product Code 240438-5) A tracheobronchial suction…
FDA Device · Class II · 2015-09-09 · Halyard Health
Reason: 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. - NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, 14F (Product Code 2V2210) A tracheobronchial suction catheter i…
FDA Device · Class II · 2015-09-09 · Halyard Health
Reason: 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. - KimVent* Multi-Access Port Closed Suction System for Adults, Endotracheal, DSY, 14 F (Product Code 24014-5) A tracheobronchial suction cath…
FDA Device · Class II · 2015-09-09 · Halyard Health
Reason: 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. - KimVent* Wet Pak* Closed Suction System for Pediatrics, 10 F, Y Adapter (Product Code 8281) A tracheobronchial suction catheter is a device…
FDA Device · Class II · 2015-09-09 · Halyard Health
Reason: 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. - KimVent Turbo-Cleaning Closed Suction System for Adults, 10 F T-Piece (Product Code 227105)
FDA Device · Class II · 2015-06-03 · Halyard Health
Reason: The internal blue flapper valve of certain KimVent Turbo-Cleaning Closed Suction System for Adults may have a potential defect. If present, the defect potentially allows air to leak out of the closed ventilator circuit. - KimVent Wet Pak, Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC
FDA Device · Class II · 2015-03-11 · Halyard Health
Reason: Defect: A hole or crack was found which may cause air to leak.