A device history record (dhr) review was performed.And all required manufacturing processes and inspection steps were confirmed, to be completed per the requirements.The device met specifications, prior to leaving abbott manufacturing facilities.Review of the sterilization records confirmed, normal sterilization cycles for the products.The product was returned and visual inspection was normal.Interrogation of the device revealed it was above elective replacement indicator (eri) when received.The cause of infection could not be traced to the device.
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