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US FDA Announces Class I Recalls For Integra, Edwards Surgical Devices

Executive Summary

The US Food and Drug Administration announced two class I recalls on 24 May. The recalls cover Integra’s LimiTorr Volume Limiting cerebrospinal fluid (CSF) drainage system and the MoniTorr intracranial pressure external CSF drainage and monitoring systems, as well as clinical platforms in Edwards’ EV1000 series.

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