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U.S. Department of Health and Human Services

Class 2 Device Recall KimVent Closed Suction System for Adults, DSE

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  Class 2 Device Recall KimVent Closed Suction System for Adults, DSE see related information
Date Initiated by Firm July 29, 2015
Date Posted August 31, 2015
Recall Status1 Terminated 3 on January 12, 2016
Recall Number Z-2511-2015
Recall Event ID 71966
Product Classification Catheters, suction, tracheobronchial - Product Code BSY
Product NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, 14F (Product Code 2V2210)
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.
Code Information Product Code 2V2210 - M5082T630, M5096T641 
Recalling Firm/
Manufacturer		 Halyard Health, Inc
5405 Windward Pkwy
Alpharetta GA 30004-3894
For Additional Information Contact Thomas Kozma, PhD
470-448-5681
Manufacturer 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.
FDA Determined
Cause 2		 Process control
Action Halyard sent a Product Advisory Notice on July 29, 2015, via FEDEX with a second letter dated August 12, 2015, being issued via FEDEX. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to report any occurrence of a valve leak to Halyard Customer Service at 1-844-425-9273, option 1, option 3.
Distribution Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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