Date Initiated by Firm |
January 01, 2007 |
Date Posted |
February 15, 2007 |
Recall Status1 |
Terminated 3 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 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 |
125 |
Distribution |
Worldwide including USA, Austria, Canada, France, Greece, Japan, Norway, Spain & Switzerland |
Total Product Life Cycle |
TPLC Device Report
|
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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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