# FDA recall Z-1310-2019

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

## Product

MoniTorr	10100	10-100	CSF Drainage System w/Patient Line One Way Valve  MoniTorr	10102	10-102	CSF Drainage System w/Patient Line One Way Valve w  MoniTorr	10110	10-110	CSF Drainage System used with Pole Mount System  MoniTorr	10140	10-140	CSF Drainage System w/Vinyl Measuring Strip  MoniTorr	10150	10-150	CSF Drainage System Simple Bag and Line  MoniTorr	10110A	10-110A	CSF Drainage System w/o Manifold Stopcock  MoniTorr	SP0017	SP0017	Special EVD 10-110 w/o Y Site Latex Free Sites  MoniTorr	SP0042	SP0042	Special EVD 10-100 w/o Y Site  MoniTorr	SP0090	SP0090	Special EVD 10-110 w/o Y Site  MoniTorr	SP0164	SP0164	Special EVD 10-140 w/Y Site & Stopcock Reverse  MoniTorr	SP0236	SP0236	INS 1100 WITH NEEDLE AT Y-ACCESS AND NEEDLELESS SI     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

## 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-1310-2019
- **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-1310-2019

## Citation

> AI Analytics. FDA recall Z-1310-2019. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1310-2019. Source: US FDA. Licensed CC0.

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