• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Alsius Cool Line

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
Alsius Cool Line
see related information
Date Posted February 15, 2007
Recall Status1 Terminated on June 22, 2007
Recall Number Z-0503-2007
Recall Event ID 37192
Premarket Notification
510(K) Number
K014241 
Product Classification System, Hypothermia, Intravenous, Cooling - 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, California 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
PRODUCTION CONTROLS: Process Control
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NCX and Original Applicant = ALSIUS CORP.
-
-