The devices were returned and evaluations are complete.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Visual inspection was performed with the following results.Four of the samples were found with no defects.The aluminum foil was not opened and the sample met specifications.Twenty-one of the samples were found to have the bottom seal opened and did not meet specifications.Eleven of the samples had the pouch peeled down from the corners along the top of the opening.These did not meet specifications.Additionally, ten packages of companion samples were inspected with no issues noted.For the 32 samples for which the reported condition was verified, the cause was determined to be related to mishandling during distribution.Should additional relevant information become available, a supplemental report will be submitted.
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