(b)(4).The device was returned for review and it was visualized that a dried residue is on the convex surface of the shell.The device was intended for treatment.No additional complaints have been reported against the manufacturing lot.This issue has been previously investigated and as part of corrective action, a new supplier for the polyethylene bags has been selected and testing completed to ensure thermal reliability and stability of the new bags.Field action z-0845-2016 was initiated on january 11, 2016 to remove remaining affected units from the field.This field action contains the related part and lot number.This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.
|