# FDA recall Z-1311-2019

> **Integra LifeSciences Corp.** · Class I · device recall initiated 2019-04-08.

## Product

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.

## Reason for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-1311-2019
- **Recalling firm:** Integra LifeSciences Corp.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-08
- **Report date:** 2019-05-29
- **Termination date:** 2021-01-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plainsboro, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1311-2019

## Citation

> AI Analytics. FDA recall Z-1311-2019. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1311-2019. Source: US FDA. Licensed CC0.

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