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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Alsius Cool Line 		see related information
Date Posted February 15, 2007
Recall Number Z-0502-2007
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, California 92618-3111
For Additional Information Contact Dr. Kenneth Collins
949-453-0150
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.
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
 
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