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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
- Date modified: