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/ 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 |
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
|