# FDA recall Z-1312-2019

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

## Product

LimiTorr	INS9020	INS-9020	LIMITORR VOLUME LIMITING EVD 20 ML  LimiTorr	INS9020SP1	INS-9020SP1	LIMITORR VOLUME EVD 20ML  LimiTorr	INS9030	INS-9030	LIMITORR VOLUME LIMITING EVD 30 ML  LimiTorr	INS9030SP1	INS-9030SP1	LIMITORR VOLUME LIMITING EVD 30 ML    Product Usage:  The LimiTorr External CSF Drainage and Monitoring Systems provides a closed system for the CSF from the ventricles of the brain or the lumbar subarachnoid space to an external drainage bag. The LimiTorr volume limiting external CSF drainage system was designed to include a volume limiting valve  mechanism which reduces the chances for excessive CSF drainage. The burette in the volume limiting external CSF drainage system contains a volume limiting valve which stops drainage when the pre-determined volume (20ml-30ml) is reached.  Indications: The LimiTorr 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 pre

## 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-1312-2019
- **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-1312-2019

## Citation

> AI Analytics. FDA recall Z-1312-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1312-2019. Source: US FDA. Licensed CC0.

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