Additional information was received for h3, h4 (for suspect lot numbers), h6, and h10.H4: suspect lot # 60398457 was manufactured 09/22/2022.H4: suspect lot # 60396825 was manufactured 09/09/2022 - 09/13/2022.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.A visual inspection of the photo observed that the valve set connector was detached from the tubing.Due to the nature of the sample, no additional evaluation could be performed.The reported condition was verified.The cause of the condition could not be determined.A batch review of the suspect lot numbers was conducted and there were no deviations found related to this reported condition during the manufacture of these lots.Should additional relevant information become available, a supplemental report will be submitted.
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