Udi information is unknown.Manufacturing site address is unknown.Premarket (510k) number is unknown.A sample was received to perform an investigation.Inspection found that the returned sample was within specification.A functional leak test was performed by manually introducing water with a syringe and the sample did not exhibit any leakage.The root cause cannot be established as the reported problem could not be confirmed with the sample received.A device history record (dhr) review was performed and found no discrepancies observed during the manufacturing of this lot.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.
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