From the device history record (dhr), lot number 20200526-23-sh was finished on 06/04/2020.No exception was recorded in the device history record that could lead to the reported incident.The average linting data is 0.149g/10 pieces.No sample was returned for the investigation.From the investigation, there is no abnormal situation which happened during production in the device history record.Therefore, the root cause could not be determined.The complaint information was informed to the relevant sectors for their awareness.There is no action taken at this time, however, we will continue to monitor the trend of this type of incident.According to supplier, or towel is made of cotton, so cotton fiber is born.Supplier continuously working with cardinal health to better control the linting and have implemented several measures to improve it: suctions machines have been installed in grey cloth rolling process, dyeing process and cutting process.The suction process was added before product's final folding, and workers do it according to standard operation procedure requirement.Linting test method and acceptable criteria was stipulated to see the suction results.(=0.38g/10pieces).In the folding process, supplier used one cloth pad under 100pieces semi-finished products to avoid linting stuck onto the products during product's transfer.
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