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U.S. Department of Health and Human Services

Enforcement Report - Week of August 22, 2012

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Product Detail

Product Description Neptune International Gold Rover Waste Management System Instructions For Use for 230V system. Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
Recall Number Z-2064-2012
Classification Class I
Code Info IFU for part 0700-002-000, all lot numbers
Product Distributed Qty 2
Reason For Recall Stryker received one report of a fatality from a customer in which the Neptune Rover was connected to a passive chest drainage tube post-operatively. Connecting the Neptune Rover (a high vacuum/high flow device), instead of using a post-operative low suction application, may have resulted in hemorrhage, which led to death.

Event Detail

Event Id 61747
Product Type Devices
Status Ongoing
Recalling Firm Stryker Instruments Div. of Stryker Corporation
City Portage
State MI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-08
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution -- USA (nationwide) and country of: Canada.