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U.S. Department of Health and Human Services

Class 2 Device Recall Neptune Rover

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  Class 2 Device Recall Neptune Rover see related information
Date Initiated by Firm October 12, 2004
Date Posted November 04, 2004
Recall Status1 Terminated 3 on March 28, 2005
Recall Number Z-0174-05
Recall Event ID 30208
510(K)Number K012991  K990037  
Product Classification Apparatus, Exhaust, Surgical - Product Code FYD
Product Stryker brand Neptune waste management system, Neptune Rover, 20 amp plug; model 0700-001-000.
Code Information All units with an Interpower brand AC power plug, which includes serial numbers 0101014 through 03227006033.
Recalling Firm/
Stryker Instruments Div. of Stryker Corporation
4100 E. Milham
Kalamazoo MI 49001
For Additional Information Contact Service Call Center
800-800-4236 Ext. 5052
Manufacturer Reason
for Recall
The grounding pin may break inside of the electrical plug, resulting in a shock hazard.
FDA Determined
Cause 2
Action Hospital customers will be sent a recall notice dated 11/09/04, new plugs for installation on their units, and instructions for installation.
Quantity in Commerce 1317
Distribution United States and Canada.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FYD and Original Applicant = AMERICAN IMMUNO TECH
510(K)s with Product Code = FYD and Original Applicant = STRYKER INSTRUMENTS