LimiTorr Volume Limiting External CSF Drainage and Monitoring System (2019-04-07)

Starting date:

April 7, 2019

Posting date:

April 18, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69644

Last updated: 2019-04-18

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  Reason
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  Affected products

Affected Products

LimiTorr Volume Limiting External CSF Drainage and Monitoring System

Reason

Integra LifeSciences identified through complaints there is a possible breakage of the LimiTorr Transducer Mount stopcock, a component of the LimiTorr Volume Limiting External CSF Drainage &Monitoring; System. A CAPA was initiated at the manufacturer to investigate the issue April 12, 2018.

Affected products