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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-01511-1
Product Name/Description	Prelude SNAP Splittable Sheath Introducer Vascular Introducer Kit Multiple Catalogue and Lot Numbers Affected ARTG 278434
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	22/12/2017
Responsible Entity	Merit Medical Australia Pty Ltd
Reason/Issue	Merit Medical Systems, Inc. is conducting a recall of specific lots of Prelude SNAP Splittable Sheath Introducers due to an intermittent failure of the splittable hub. Merit Medical has received complaints indicating that the wings on certain lots of the Prelude SNAP have broken off the sheath hub during splitting. This will likely result in a minor delay in procedure. Although rare, this could also result in a pacing lead/catheter displacement, air embolus, or minor hemorrhage. Merit has received no reports of patient harm or injury as a result of this issue.
Recall Action	Recall
Recall Action Instructions	Users are advised to check inventory for affected devices and discontinue their use. Affected stock should be returned to Merit Medical. This action has been reviewed and is considered complete in accordance with the requirements of the URPTG.
Contact Information	03 8373 4943 - Merit Customer Service