H4: the lot was manufactured between january 23, 2023 and january 24, 2023.H10: the device was received for evaluation.A visual inspection was performed and observed liquid inside the housing which indicated a leak may have occurred.The reported condition was verified.The cause of the condition was determined to be a missing film-wrap located at the upper part of the bladder which is a manufacturing issue.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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