No sample was returned for evaluation.A review of the batch production record for the given lot showed no unusual manufacturing issues.A review of the complaint records showed one other complaint against the given lot.That complaint was for issues with the control valve.A review of confirmed complaints for regulators with low or no flow showed with no additional, related information provided, the customer reported event was not confirmed.The root cause cannot be determined conclusively.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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