An open seal defect was detected during internal rework activities. Investigation determined that the preliminary cause of issue was a machine failure, leading to the zipper tray to be incorrectly positioned in the copolymer pre-formed cavity and subsequent tray misalignment with the front seal area in the sealing process. This ultimately resulted in possibility of open seal condition and/or narrow seal defects in the subsequent units. Recall start date: December 30, 2024
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