Class 2 Device Recall Neptune Rover

• Date Initiated by Firm: October 12, 2004
• Date Posted: November 04, 2004
• Recall Status: Terminated on March 28, 2005
• Recall Number: Z-0175-05
• Recall Event ID: 30208
• Product Classification: Apparatus, Exhaust, Surgical - Product Code FYD
• Product: Stryker brand Neptune waste management system, Neptune Rover, 15 amp plug; model 0700-003-000.
• Code Information: All units with an Interpower brand AC power plug, which includes serial numbers 0203177 through 0406301403.
• FEI Number: 1811755
• Recalling Firm/ Manufacturer: 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: Other
• 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: 365
• 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.