Class 2 Device Recall Warm Air Model !35

• Date Initiated by Firm: November 05, 2004
• Date Posted: December 30, 2004
• Recall Status: Terminated on October 29, 2008
• Recall Number: Z-0374-05
• Recall Event ID: 30414
• 510(K)Number: K942599
• Product Classification: unknown device name - Product Code BTE
• Product: Warm Air Model 135 Warming Units.
• Code Information: All serial numbers.
• Recalling Firm/ Manufacturer: Cincinnati Sub-Zero Products; 12011 Mosteller Rd; Cincinnati OH 45241-1528
• For Additional Information Contact: Crystal Morrison; 513-772-8810
• Manufacturer Reason for Recall: Burning smell, burned microprocessor board. The firm is modifying the connectors and wiring gauge configuration of the device.
• FDA Determined Cause: Other
• Action: The firm notified consignees by certified letter on November 5, 2004.
• Quantity in Commerce: 649 units.
• Distribution: The product was distributed throughout the United States and to foreign countries including Saudi Arabia, Taiwan, Japan, and Canada.

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 = BTE and Original Applicant = CINCINNATI SUB-ZERO PRODUCTS, INC.