Date Initiated by Firm |
October 12, 2004 |
Date Posted |
November 04, 2004 |
Recall Status1 |
Terminated 3 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. |
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 2 |
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
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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.
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