H4: the lot was manufactured between august 31, 2022 and september 02, 2022.H10: the actual devices were not available; however, ten (10) unopened companion samples were received for evaluation.Unaided eye visual inspection was performed, and no defect was observed for all samples.System level leak testing was performed on an in-lab compounder with 1 randomly selected sample from the 10 samples received (same lot and cavity) and no issues were observed.The reported condition was not verified on the companion samples.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.
|