(b)(4).Reported device not marketed in the u.S., however, similar devices or devices that share components, (b)(4) materials, process methods or other technological characteristics are registered within the u.S.K990090.When additional information is received a follow up report will be submitted.
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Samples received: there are no samples available for analysis.Analysis and results: there are no previous complaints of this code-batch.We manufactured and distributed in the market 63,648 units of this code-batch.There are no units in our stock.We have not received any sample for analysis.Without any closed sample we cannot carry out an analysis in order to take a decision.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil usp/ep and b.Braun surgical requirements.Remarks: when working with dafilon suture materials great care should be taken to ensure that the use of surgical instruments, such as tweezers and needle holders do not damage the material by being pinched or kinked.Final conclusion: without samples we are not in position of studying if the affected product does not fulfil the specifications.In consequence, a proper analysis cannot be done and the case is not confirmed due to lack of evidence.Nevertheless, we take note of this incidence and if any sample is received in the future, we will re-open the case and analyze it.Please note that when no samples are received our analysis is very limited.Actions on product distributed of this reference/batch: based on the conclusion derived from investigation, it is not required to make actions in distributed product.No corrective/preventive actions needed.
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