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U.S. Department of Health and Human Services

Class 2 Device Recall Neptune 2 Rover Ultra

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 Class 2 Recall
Neptune 2 Rover Ultra
see related information
Date Posted December 03, 2012
Recall Status1 Terminated on May 28, 2014
Recall Number Z-0455-2013
Recall Event ID 63634
Product Classification Apparatus, Suction, Ward Use, Portable, Ac-Powered - Product Code JCX
Product Neptune® 2 Rover - ULTRA ~230V ~ 50 Hz 12A REF 0702-002-000, Rx Caution, consult accompanying documents Consult instructions for use, Max Vacuum; 21.0 in-Hg, 530 mm-Hg, The Neptune Waste Management System consists of a mobile rover unit used to suction and collect fluid waste, small debris and electrocautery smoke from a surgical site. Mobility allows the rover unit to be relocated to a waste disposal area where the rovers collection canisters can be emptied, via the docking station. Intended to be used in the Operating Room, Surgical Centers and Doctors Offices to collect and dispose of surgical fluid waste as well as collect smoke from electrocautery or laser devices.
Code Information Part 0702-002-000 (230v) Lot 0733700353 through 1036100423
Recalling Firm/
Manufacturer
Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage, Michigan 49002-9704
For Additional Information Contact K. Kelly Smith
269-389-3584
Manufacturer Reason
for Recall
Beginning May 24, 2011 Stryker Neptune 2 (N2) Waste Management Systems castors were replaced with a new castor design because investigation found the old design had the potential for the casters to bind compromising the Rover's ability to roll. This can result in additional strain on the operator, due to multiple exposures resulting in back pain.
Action Stryker Instruments sent a "STRYKER NEPTUNE 2 ULTRA 120V & 230V WASTE MANAGEMENT SYSTEM" letter dated June 22, 2011 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were asked to complete and return a Reply Form via fax to Stryker at 269-906-9121 or email to sales.service@stryker.com. Technical questions should be addressed to Neptune Field Service at 800-800-4236 ext. 5052.
Quantity in Commerce 154
Distribution Worldwide Distribution-USA (nationwide) and Pacific countries, and the countries of EEMEA, Canada, Latin America, and Japan.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
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