Correction made to e1: (b)(6).H4: the lot was manufactured between january 28, 2023 ¿ january 29, 2023.H10: three (3) devices were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.System level testing was performed, and the reported issue was not observed.Functional testing was performed by installing each valve set sample onto ca ompounder and no issue was observed during testing.No issues were observed during the prime and verify process and pump calibration process.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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