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Neptune 2 Waste Management System - Rover (2014-01-24)
- Starting date:
- January 24, 2014
- Posting date:
- March 18, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-38299
Recalled Products
Neptune 2 Waste Management System - Rover
Reason
The purpose of this correction is to upgrade the Neptune 2 Waste Management System to the new approved specifications. Previously, Stryker had received reports that the Neptune 2 had been connected directly to a chest tube, postoperatively which resulted in fatalities and injuries. The new approved specifications include a change in technology, a control mechanism change as well as a modification to the canister vacuum level regulator (from mechanical to electrical). The Neptune 2 has been re-designed to address the hazards and harms outlined in previously recalls.
Affected products
Neptune 2 Waste Management System - Rover
Lot or serial number
All lots
Model or catalog number
0702-001-000
Companies
- Manufacturer
-
Stryker Instruments
4100 East Milham Ave.
Kalamazoo
49001
UNITED STATES