A review of the device history record for lot number 201007-18-sh revealed it was manufactured on november 21st, 2020.No exception was recorded in the device history record that could lead to the reported incident.The average linting data is 0.149g/10pcs.No sample available for investigation, but photos were provided.A review of the photos revealed lint was found on hands.According to supplier, operating room towel is made of cotton, so cotton fiber is born.The supplier is 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.(b)(4).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.The investigation determined no abnormal situation happened during production; therefore, the root cause could not be determined.The complaint information was shared with the relevant sectors for their awareness.No action taken at this time, but the supplier will continue to monitor the trend for this type of incident.
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