Date Initiated by Firm |
January 18, 2005 |
Date Posted |
April 06, 2005 |
Recall Status1 |
Terminated 3 on September 21, 2007 |
Recall Number |
Z-0670-05 |
Recall Event ID |
30820 |
Product Classification |
Pack, Hot Or Cold, Water Circulating - Product Code ILO
|
Product |
Electri-Cool II |
Code Information |
All units manufactured from 3/04-5/04. |
Recalling Firm/ Manufacturer |
Cincinnati Sub-Zero Products Inc 12011 Mosteller Rd Cincinnati OH 45241-1528
|
For Additional Information Contact |
Crystal Morrison 513-772-8810
|
Manufacturer Reason for Recall |
There is the potential that the power switch assembly can dislodge from the cabinet during use.
|
FDA Determined Cause 2 |
Other |
Action |
The firm sent a recall letter by certified mail, dated 1/18/05, to consignees. |
Quantity in Commerce |
130 devices |
Distribution |
The devices were distributed throughout the United States. |
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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