Halyard Health
Halyard Health holds FDA 510(k) medical device clearances, first cleared 2014, most recent 2019, with 9 FDA device recalls on record.
Top product codes for Halyard Health
FDA recalls by Halyard Health
- Z-0758-2017 — Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile.
- Z-1220-2015 — KimVent Closed Suction System for Adults, Double Swivel Elbow, 12 Fr., Sterile, Distributed by Kimberly Clark Global Systems, LLC.
- Z-1221-2015 — KimVent Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.
- Z-1222-2015 — KimVent Wet Pak, Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.
- Z-0865-2015 — KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
- Z-0868-2015 — KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.5 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
- Z-0866-2015 — KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.5 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
- Z-0869-2015 — KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 9.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
- Z-0867-2015 — KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Halyard Health
- K181360 — ON-Q* Pump with Bolus
- K180646 — Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
- K161232 — ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit
- K160709 — HALYARD* PURPLE NITRILE XTRA* Powder-Free Exam Gloves
- K153708 — Halyard Black-Orange Powder-Free Nitrile Exam Glove
- K150113 — Fusion Black Powder-Free Nitrile Exam Glove
- K141712 — KIMGUARD ONE STEP STERILIZATION WRAP
Data sourced from openFDA. This site is unofficial and independent of the FDA.