Investigation summary: an internal complaint ((b)(4)) was received for a convenience kit (part 89-2569, lot 50224803) that contained or towels that created lint during a surgical procedure.A sample was returned 9/4/2019 and confirmed the reported issue.The work order for the reported lot was reviewed for possible discrepancies that may have contributed to the event.No discrepancies were identified.The bill of material for the kit was reviewed and raw material 1060988 was identified as the affected or towel, which is purchased in bulk from a supplier, s2s global.A supplier corrective action request has been sent to s2s global.The returned sample also was forwarded to the supplier for evaluation.As of the date of this report, a response has not been received.The investigation is ongoing at this time.When new and critical information is received, this report will be updated.
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