Recall Z-2510-2015— Halyard Health, Inc
Class II · Terminated
Class II FDA medical device recall by Halyard Health, Inc, initiated 2015-07-29, terminated 2016-01-12. FDA's recall record names no specific 510(k) clearance for this event. 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 patient's upper airway.. 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..
- Recalling firm
- Halyard Health, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-07-29
- Terminated
- 2016-01-12
- Firm location
- Alpharetta, GA, United States
Product description
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 patient's upper airway.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.