Class 2 Device Recall Microtemp II.

• Date Initiated by Firm: January 18, 2005
• Date Posted: April 06, 2005
• Recall Status: Terminated on September 21, 2007
• Recall Number: Z-0671-05
• Recall Event ID: 30829
• 510(K)Number: K843146
• Product Classification: Pack, Hot Or Cold, Water Circulating - Product Code ILO
• Product: Micro-temp II heat therapy unit, model #747.
• Code Information: All units containing version 0.70 software.
• 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: Other
• Action: The recalling firm sent letters, dated 1/18/04.
• Quantity in Commerce: 553 devices.
• Distribution: The product was distributed to hospitals throughout the United States.
• 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 = ILO