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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00827-1
Product Name/Description	KIMVENT Closed Suction Systems (Tube, tracheal, general-purpose, single-use) KimVent Closed Suction System - Neonates/Paediatrics, 5F, 6F and 8F Y Adpater 5F Lot #: M5067T05 & M5076T402 6F Lot #: M5054T512 8F Lot #: M5089T503 & M5082T502 KimVent Closed Suction System - Adults, 14F, DSE Lot #: M5085T604 KimVent Turbo-Cleaning Closed Suction System - Adults, 12F, DSE Lot #: M5096T306 KimVent Turbo-Cleaning Closed Suction System - Adults, 14F, DSE Lot #: M5080T301 ARTG: 129684
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	4/09/2015
Responsible Entity	Kimberly Clark Aust Pty Ltd
Reason/Issue	There is a potential that the thumb valve of a very small percentage of KIMVENT Closed Suction Systems can remain partially open after suctioning was completed, even though the valve appeared to be closed or in the “LOCKED” position. This situation can result in a partial air leak from the ventilator circuit triggering the ventilator alarm and replacement of the closed-suction device.
Recall Action	Recall for Product Correction
Recall Action Instructions	Halyard Health is providing work around instructions to assist end users correct valve leaks caused by this issue. Halyard Health is undertaking an investigation to prevent this issue from occurring. This action has been closed-out on 18/08/2016.
Contact Information	1800 101 021 - Halyard Customer Service