Two (2) devices were received for evaluation.Visual inspection revealed particulate matter on the outside wall of the inner pouch of both units.Microscopic inspection revealed that the particulate matter was a fiber.The reported particulate matter condition was verified; however, the size of the particulate matter was found to be within specification for this product.The samples met specification.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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