A sample was not received at the manufacturing site for evaluation for the report of there was leaking trocars; therefore, the condition of the product could not be verified.Even though no lot number was identified with this complaint; our products are processed and released according to the product¿s acceptance criteria.A sample was not received at the manufacturing site and no lot information is available, therefore, the root cause for the customer complaint issue cannot be determined.Investigations have been completed and manufacturing process enhancements have been implemented in order to improve the performance of the valves.The manufacturer internal reference number is: (b)(4).
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