(b)(4).The customer returned a trach-vent filter, along with a tracheostomy tube.A visual exam was performed and it was observed that the tracheostomy tube is not a teleflex product.No defects were observed on the trach-vent filter.The manufacturing site reports "15mm plug gauge test was conducted on the connector of the sample, the connector side is in the specification according to iso 5356-1:2015.In current manufacturing procedure, incoming quality check (iqc) department shall conduct sampling gauge test before release the part item to production.In production, 100% visual inspection at assembly area is conducted.Thus, any ineffective products will be culled out during this process.Therefore, it is very unlikely condition at the manufacturing area that the product having defect to be released for shipment." the complaint could not be confirmed.
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