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U.S. Department of Health and Human Services

Class 2 Device Recall Alsius Cool Line

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  Class 2 Device Recall Alsius Cool Line see related information
Date Initiated by Firm January 01, 2007
Date Posting Updated February 15, 2007
Recall Status1 Terminated 3 on June 22, 2007
Recall Number Z-0502-2007
Recall Event ID 37192
510(K)Number K014241  
Product Classification Patient Thermal Regulation System - Product Code NCX
Product Alsius Cool Line Catheter, Model CL-2295A
Code Information Lot numbers: 16174
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 2
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 77
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 and Original Applicant = ALSIUS CORP.
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