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Medical Devices / Submissions and Approvals

Integra LifeSciences Recalls Drainage Devices Over Fragile Valves

May 23, 2019

The FDA flagged a Class 1 recall by Integra LifeSciences of two of its drainage devices, citing potential breakage of their external valves.

The firm pulled its MoniTorr and LimiTorr products—devices used in the drainage of cerebrospinal fluid from the ventricles of the brain or lumbar subarachnoid space—after receiving a series of complaints.

The complaints indicated that the devices’ externally operated valves, which regulate the flow of cerebrospinal fluid into a drainage bag, were breaking while users tightened the connections. The company warned that the connections should be just “finger tight.”

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