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Type of Product	Medical Device
TGA Recall Reference	RC-2024-RN-00213-1
Product Name/Description	Cannulae Devices Multiple Product, Model and Lot numbers ARTG's 123150, 126007, 127640, 147722, 148992, 148994, 149721, 152502, 154997, 154998, 154999, 155002, 155977, 289357, 289358, 299275
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	15/03/2024
Responsible Entity	Medtronic Australasia Pty Ltd
Reason/Issue	Medtronic is advising of a potential sterility breach for specific lots of the Cannulae products following a customer report indicating that, prior to use of a DLP I.M.A. Cannula, the sterile packaging was not sealed. Seven (7) pouched devices were returned in December 2023, and it was confirmed there were several un-sealed areas with no adhesive transfer from the Tyvek onto the formed film. Medtronic has determined that all models and lot numbers listed in the attached customer letter could potentially exhibit a sterility breach.
Recall Action	Recall
Recall Action Instructions	Customers should; · Review their inventory for listed product. · Immediately identify and quarantine all unused, listed product in their inventory. · complete the customer acknowledgment for so Medtronic can organise return of affected product. · Share this notification with others in their organisation and if product has been forwarded to another facility, please notify the facility of this Recall.
Contact Information	0450 727 450 - Gav Aiyer