Additional information was provided in sections h.6 and h.10.There was no sample returned.Therefore, testing could not be performed.An analysis of the retain samples lot(s) showed that the product was perfluoropropane (pfp) and met all release criteria.Based upon the information obtained, a root cause cannot be conclusively determined.Based upon the information obtained, a root cause 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).
|