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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