Class 2 Device Recall Alsius Cool Line

• Date Initiated by Firm: January 01, 2007
• Date Posted: February 15, 2007
• Recall Status: Terminated on June 22, 2007
• Recall Number: Z-0503-2007
• Recall Event ID: 37192
• 510(K)Number: K014241
• Product Classification: Patient Thermal Regulation System - Product Code NCX
• Product: Alsius Cool Line Catheter, Model CL-2295AE
• Code Information: Lot numbers: 16243 & 16292
• Recalling Firm/ Manufacturer: Alsius Corporation; 15770 Laguna Canyon Rd Ste 150; Irvine CA 92618-3111
• For Additional Information Contact: Dr. Kenneth Collins; 949-453-0150
• Manufacturer Reason for Recall: Testing by Alsius has identified that 6-10% of catheters from the three affected lots may exhibit a significant reduction in their heat exchange capacity.
• FDA Determined Cause: Other
• Action: Customer letters were sent starting January 1, 2006 via FEDEX and DHL. Verification of receipt of the notification letter to level A will be undertaken by using tracked delivery requiring signature upon receipt . The Customer letters will notify consignees of the nature of the problem and provide instructions to return the product.
• Quantity in Commerce: 125
• Distribution: Worldwide including USA, Austria, Canada, France, Greece, Japan, Norway, Spain & Switzerland
• 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 = NCX