Health product recall

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

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

LimiTorr Volume Limiting External CSF Drainage and Monitoring System

Lot or serial number

Not applicable.

Model or catalog number

INS-9020

Companies
Manufacturer

Integra Lifesciences Corp.

311 Enterprise Drive

Plainsboro

08536

New Jersey

UNITED STATES