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Type of Product	Medical Device
TGA Recall Reference	RC-2023-RN-00002-1
Product Name/Description	HLS Set Advanced and the PLS Set Reference numbers: BE-PLS 2050, BE-PLS 2051, BO-PLS 2051, BE-HLS 7050, BE-HLS 5050, BO-HLS 7050, BEQ-HLS 7050 USA & BEQ-HLS 5050 USA 29/6/2023 Update: BEQ-HLS 7050-CA, BEQ-HLS 5050-CA, BE-HLS 7050 Japan Article numbers: 701068386, 701068389, 701068390, 701069073, 701069076, 701069083, 701069078 & 701069077 29/6/2023 Update: 701069065, 701069068, 701077943 ARTG 192105 & 193475
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	1/02/2023
Responsible Entity	Getinge Australia Pty Ltd
Reason/Issue	Getinge Australia is advising of a potentially compromised sterile barrier regarding the HLS Set Advanced and the PLS Set. The manufacturer, Maquet Cardiopulmonary GmbH (MCP), has received a communication from a regulatory body in which the conformity of the products was questioned due to packaging tests not being adequately performed. Parallel to that, the respective tests were repeated with samples under market conditions. The samples are conditioned as described in the current market specification; single sterilised and transport conditioned according to ASTM D4169-22. However, the test samples were not double sterilised to cover an assumed worst condition of sterilisation impact. No customer complaints were received due to this potential non-conformity.
Recall Action	Product Defect Alert
Recall Action Instructions	Getinge advise that due to a potential delay of replacement products, customers have two options: 1. Return all affected products to Getinge for a credit. If a product is already in use, it should remain in use. 2. Update:8/2/2023 - customers should note that at this time, Getinge can only provide devices with the non-conformity described. The user must carry out a risk assessment of the risk of using a potentially non-sterile medical device. The devices can continue to be used by following the Instruction for use. Update: 9/5/2023 - An investigation determined that the planned corrective actions were not fully implemented. Maquet Cardiopulmonary´s Notified Body decided to suspend the CE Certificate until appropriate corrections can be implemented. The continued supply of devices to the market is currently permitted only under special authorisation. Consult your local Getinge representative to verify the impact of this decision in your market.
Contact Information	1800 438 464 - Getinge Customer Service