On (b)(6) 2020, the end-user reported a debris found on a reusable surgical gown (7005) while setting up the case.The gown was inside a spine pack 123668.The gown was not sent back to the facility for testing.Awareness documented training was provided to the employees.Historical review of titration reports, no quality exceptions were recorded.Review of the product that the customer orders and discussion on barrier levels.Review our processes and procedures; no updates needed.The root cause for the reported issue is wearing the wrong barrier level product for a orthopedic hip procedure.There is no additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
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