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Neptune and Neptune 2 Waste Management Systems - Rover (August 23, 2013)

Starting date:
August 23, 2013
Posting date:
August 23, 2013
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-35541

Reason

Stryker has received additional reports of serious injury or death in procedures where the Neptune was connected to a passive chest drainage tube or closed wound drainage device post-operatively. As a result of the additional reported adverse events as well as information suggesting that not all users of the Neptune devices were trained on the risks associated with using the device, stryker is requiring additional actions to be implemented in order for facilities to continue use of their Neptune device(s).

Affected products

A. Neptune 2 Waste Management System - Rover

Lot or serial number

All lots

Model or catalog number

0702-001-000

Companies

Manufacturer
Not Applicable



B. Neptune Rover

Lot or serial number

All lots

Model or catalog number

0700-003-000

Companies

Manufacturer
Not Applicable