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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Integra Class I recall: Firm's NeuroSciences unit initiated a recall Oct. 3 of its Gravity Compensating Accessory (GCA) used in implanted shunt systems because the device may leak cerebrospinal fluid, potentially causing inflammation of brain, spinal cord or abdominal membranes, or failure of the shunt system, FDA says in a Dec. 11 Class I recall notice. The GCA is part of a system that redirects excess fluid from the brain to the abdomen so that too much fluid does not build up while sitting or standing. Integra sent letters to customers on Oct. 9, as well as to physicians. The devices were manufactured between January and May, and were distributed from Feb. 22 to June 1

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