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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-01295-1
Product Name/Description	4F Stiffened Micro-Introducer Kits (guidewire or catheter introducer) Product Description: STF 4F M.I. KIT 45CM NT/T ECHO S PG Catalogue Number: 06597052 Lot Numbers: 5031722 & 5043440 ARTG Number: 172522
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	11/10/2016
Responsible Entity	Medical Specialties Australia Pty Ltd
Reason/Issue	AngioDynamics, Inc., the manufacturer of the 4F Stiffened Micro-Introducer Kits, has become aware of the potential with respect to the 4F sheath/dilator components for the rotating luer to detach from the dilator hub during use. Use of the affected AngioDynamics Stiffened Micro-Introducer Kits may result in patient harm, including minor tissue trauma and/or minor delay in procedure to replace the device.
Recall Action	Recall
Recall Action Instructions	Medical Specialties Australia have contacted affected customers and retrieved all unused product. This action has been closed-out on 24/05/2017.
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