Additional information was provided in sections h.6 and h.10.There was no sample was returned.Therefore, testing could not be performed.An analysis of the retain samples lots showed that the product was pfp and met all release criteria.Based upon the information obtained, the root cause of the reported event cannot be conclusively determined.Based upon the information obtained, the root cause of the reported event cannot be conclusively determined.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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