Health Canada — Medical Devices · Canada · 2023-04-06 · Type II
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Reported risk: During the execution of 2 year real time aging, an issue was identified during bubble testing where there was a leak in the sealed sterile barrier of the packaging. Further investigation determined the manufacturing work instruction was not aligned to the design drawing. It was determined during review of the dv failure that the breach of the sterile barrier was related to the incorrect placement of the IFU during the packaging process. Recall start date: March 24, 2023
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