The device was not returned to the mfr for physical eval and the lot number was not able to be obtained to date.Distribution records were reviewed to identify potential lots of this product shipped to the customer within the past three months.An alternate sample from one of the lots from the distribution ctr was returned for investigation and no defects were noted.In addition, an investigation of the device mfg records was conducted by the mfr.There were no deviations or nonconformities during the mfg process.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.
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