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U.S. Department of Health and Human Services

Class 2 Device Recall ElectriCool II

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 Class 2 Device Recall ElectriCool IIsee related information
Date Initiated by FirmJanuary 18, 2005
Date PostedApril 06, 2005
Recall Status1 Terminated 3 on September 21, 2007
Recall NumberZ-0670-05
Recall Event ID 30820
Product Classification Pack, Hot Or Cold, Water Circulating - Product Code ILO
ProductElectri-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 ContactCrystal 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
ActionThe firm sent a recall letter by certified mail, dated 1/18/05, to consignees.
Quantity in Commerce130 devices
DistributionThe devices were distributed throughout the United States.
Total Product Life CycleTPLC 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.
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