This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during the device history record review.One sample was received in decontaminated conditions inside a plastic bag without its original packaging.Visual inspection was performed at 12 to 16 inches under normal conditions of illumination.During the visual inspection it was observed that the sample did not contain the blue clip.During the functional testing, water could pass through without problem, no discrepancies were detected when the pump was put into operation, no alarm was activated; thus, the failure mode is not confirmed.Root cause cannot be determined since the complaint was not confirmed due to the fact the sample tested was successfully passed.No corrective action required as the complaint was not confirmed.
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