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Uvula Retractor (Karl Storz) – Reprocessing Validation (2024)

Inadequate reprocessing validation evidence

FDAFeb 27, 2024Nationwide• Karl Storz Endoscopy

Blood Pressure Unit (MEDLINE) – Manufacturing Specification (2024)

The firm provided a set of specifications for the device, but some units of the device were manufactured non-compliant with the specifications. However, the firms Receiving Dept. accepted these units into inventory

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FDAFeb 26, 2024Nationwide• MEDLINE INDUSTRIES, LP Northfield

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Uvula Retractor (Karl Storz) – Reprocessing Validation (2024)

Blood Pressure Unit (MEDLINE) – Manufacturing Specification (2024)

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