Halyard Health

FDA Regulatory Profile

Summary

Total Recalls
57 (5 Class I)
510(k) Clearances
14
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1428-2018Class IIHalyard Closed Suction System for Adults, Turbo- cleaning¿Closed¿Suction¿System¿for¿Adults,¿Double¿SFebruary 7, 2018
Z-1427-2018Class IIHalyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to aspirate liquids or semFebruary 7, 2018
Z-1429-2018Class IIHalyard Closed Suction System for Adults, Multi-Access¿Port¿Closed¿Suction¿System¿for¿Adults. Used February 7, 2018
Z-1277-2018Class IICORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagnetic Transmitting StyletDecember 13, 2017
Z-0124-2018Class IIHalyard Closed Suction System for Adults, 14 F, T-Piece, MDI, Wet Pak. 12 vials per kit, 20 kits perOctober 6, 2017
Z-0120-2018Class IIHalyard Closed Suction System for Adults, 14 F, Elbow, Directional Tip, Wet Pak. 12 vials per kit, 2October 6, 2017
Z-0123-2018Class IIHalyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI, Wet Pak. 12 vials per kit, October 6, 2017
Z-0119-2018Class IIHalyard Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 or 6 vials per kit, 20 kits per casOctober 6, 2017
Z-0121-2018Class IIHalyard Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece, Wet Pak. 12 vials per kit, 2October 6, 2017
Z-0122-2018Class IIHalyard Closed Suction System for Adults, 14 F, T-Piece, Wet Pak. 12 or 6 vials per kit, 20 kits perOctober 6, 2017
Z-0125-2018Class IINOVAPLUS* Endotracheal WET PAK* Closed Suction System for Adults with BALLARD* Technology, Double SwOctober 6, 2017
Z-0117-2018Class IIHalyard Closed Suction System for Adults with BALLARD Technology WET PAK. 12 saline vials per kit, 2October 6, 2017
Z-0118-2018Class IIHalyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 saline vials per kitOctober 6, 2017
Z-0758-2017Class IISterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile.November 10, 2016
Z-0724-2017Class IIHalyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Product Code 44965 NS; C-SeNovember 9, 2016
Z-2391-2016Class IICoolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a RadiofreJune 16, 2016
Z-2505-2015Class IIKimVent* Wet Pak* Closed Suction System for Adults, 14 F, Elbow (Product Code 2276); KimVent* Wet PaJuly 29, 2015
Z-2521-2015Class IIKimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Manifold (Product Code 201) A tracheobJuly 29, 2015
Z-2522-2015Class IIKimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Elbow (Product Code 206); KimVent* ClosJuly 29, 2015
Z-2509-2015Class IIKimVent* Closed Suction System for Adults, 14 F, DSE, DT (Product Code 22109) A tracheobronchial suJuly 29, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K181360ON-Q* Pump with BolusMarch 22, 2019
K180646Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy DrugsJune 27, 2018
K173955Mic-Key* SF Over-the-Wire Stoma Measuring DeviceJanuary 26, 2018
K162930Aero Chrome* Select Breathable Performance Surgical GownsApril 21, 2017
K163461Coolief* Cooled RF ProbeApril 13, 2017
K163236COOLIEF Cooled Radiofrequency KitDecember 16, 2016
K161232ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block KitSeptember 30, 2016
K160709HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam GlovesSeptember 6, 2016
K153255Aero Chrome* Breathable Performance Surgical GownApril 13, 2016
K153708Halyard Black-Orange Powder-Free Nitrile Exam GloveMarch 31, 2016
K150113Fusion Black Powder-Free Nitrile Exam GloveJune 18, 2015
K143287Fluidshield* Surgical Mask with Expanded ChamberMarch 24, 2015
K143095MiniStim MS-IVB Peripheral Nerve StimulatorMarch 24, 2015
K141712KIMGUARD ONE STEP STERILIZATION WRAPDecember 18, 2014