Model number/catalog number: sc-8216-50, serial/batch number: (b)(4), model/catalog description: artisan lead 50 cm, model number/catalog number: sc-1200, serial/batch number: (b)(4).Model/catalog description: precision montage mri ipg.The explanted devices were not returned to bsn as they were kept by the medical facility.A review of the manufacturing documentation for the devices revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.A review of the sterilization documentation for the devices was found to be satisfactory.
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