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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00805-1
Product Name/Description	Medtronic DLP Adapters and Pressure Display Sets DLP Extension Line Adapters 20 in length Product Code: 11001G DLP Antegrade/Retrograde Adapter Product Code: 13001 DLP Cardioplegia Adapter with Pressure Port Product Code: 15004 DLP Pressure Monitoring Extension Line Adaptors Product Codes: 25009, 25010 DLP Pressure Disposable Pressure Display Sets Product Codes: 61000, 62000 ARTG Numbers: 126007 and 130994
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	22/06/2017
Responsible Entity	Medtronic Australasia Pty Ltd
Reason/Issue	Medtronic recently identified small pinholes approximately 1mm or less in diameter in single packaging configuration. Medtronic has performed an internal investigation and all products configured and manufactured since March 1 2016 are potentially affected. This result is a potential sterile barrier breach. Zero complaints have been received for the affected lots. Potential patient harm is infection, which could result in secondary harm if a sterile barrier breach in the packaging is present, but not detected prior to use.
Recall Action	Recall
Recall Action Instructions	Medtronic is Recalling affected stock from the Market. This action has been closed out on 25/06/2019
Contact Information	02 9857 9381 - Medtronic