It was reported that the customer received a partial order of quite a few goodwin sound replacements as it consistently had issues with rust and discoloration in the lumen.Also stated that upon receiving the new replacements, they were inspected with a borescope and discoloration was noted prior to any reprocessing.Per notification from investigator on (b)(6) 2022 based on sample returned, it was reported that the dilation catheters were corroded.
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It was reported that the customer received a partial order of quite a few goodwin sound replacements as it consistently had issues with rust and discoloration in the lumen.Also stated that upon receiving the new replacements, they were inspected with a borescope and discoloration was noted prior to any reprocessing.Per notification from investigator on 04feb2022 based on sample returned, the additional records were created based on the material numbers of the samples received.The returned material numbers were (042814), (042816), (042820), (042824), (042826) and (042828).
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