Recall Z-0502-2007 ยท NCX System, Hypothermia, Intravenous, Cooling
Alsius Corporation
Alsius Cool Line Catheter, Model CL-2295A
| Date | Feb 15, 2007 (initiated Jan 1, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root 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 | 77 |
| Distribution | Worldwide including USA, Austria, Canada, France, Greece, Japan, Norway, Spain & Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K014241 | COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D Alsius Corp., Aug 1, 2003 |