KimVent* Closed Suction System for Adults, 14 F, DSE, DT (Product Code 22109) 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.
FDA Recall Z-2509-2015 · Posted 2015-08-31
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Recalling FirmHalyard Health, Inc
Recall StatusTerminated
Product CodeBSY
Date Initiated2015-07-29
Date Terminated2016-01-12
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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