Integra LifeSciences Corp. recalls MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System Product Usage: The MoniTorr ICP External CSF…

Recall date

April 8, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1311-2019

FDA classification

Class I

Brand / firm

Integra LifeSciences Corp.

Sold / distributed

Worldwide Distribution - US Nationwide International distribution to Argentina, American Samoa, Australia, Canada, and Guam.

Why it was recalled

The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System Product Usage: The MoniTorr ICP External CSF Drainage and Monitoring Systems provide a simple to use, closed system for the drainage of cerebrospinal fluid (CSF) from ventricles of the brain or the lumbar subarachnoid space to a drainage bag. The system may be used with a pole mounted assembly that allows for simple, quick and accurate alignment with the patient and secure positive or negative pressure level setting. The system also has been designed to provide for ease of patient transport through a compact design and antimicrobial hydrophobic vent feature that resists occlusion. Indications: The MoniTorr ICP system allows for drainage and monitoring of CSF from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF inpatients with infected CSF shunts, and to monitor ICP.