H4: the lot was manufactured between march 31, 2023 - april 01, 2023.H10: two (2) devices were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition in either set.Neither unit had been filled with fluid by the customer.No evidence of damage was noted.Both units underwent leak testing, and neither set was noted to be leaking.The reported condition was not verified.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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