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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00712-1
Product Name/Description	Waratah Private General Packs and Waratah Private Knee/Shoulder Arthro Pack (Surgical procedure packs) Waratah Private General Pack Catalogue number (SKU) : 97035035-05 Batch numbers: 15030983, 15038366, 15077945, 15100388 Waratah Private Knee/Shoulder Arthro Pack Catalogue number (SKU): 97067575-00 Batch number: 15035436 ARTG Number: 133565
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	4/08/2015
Responsible Entity	Molnlycke Health Care Pty Ltd
Reason/Issue	Following notification from component supplier, ConvaTec Ltd concerning the 3m Suction Tube contained in some procedure packs, Mölnlycke is issuing this recall for product correction notice for packs containing this suction tubing. ConvaTec conducted an internal assessment of product complaints that they had received and has identified that the suction tubes are not meeting their manufacturer's specifications. Specifically, the connector part for application to the suction devices in the LOTs affected by the recall, has failed to meet its required reliability. The connector parts of the specified LOTs have a higher probability to crack once applied to suction devices outlets.
Recall Action	Recall for Product Correction
Recall Action Instructions	Customers are advised to isolate all affected, unused packs at their facility and contact Mölnlycke representative for alternative single packed sterile suction tubing. At the point of use, it is recommended that the users remove the ConvaTec 3m Suction Tube and dispose of the product, replacing it with a single packed sterile version. If customers or users have any issues with the above recommendation, please send the affected packs back to Mölnlycke for a full refund. This action has been closed-out on 15/08/2016.
Contact Information	61 2 89772114 - Regulatory and Quality Affairs Specialist