Alsius Cool Line Catheter, Model CL-2295A
FDA device recall Z-0502-2007 · posted 2007-02-15 · Terminated
Recall details
- Recalling firm
- Alsius Corporation
- 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 taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- NCX
- Quantity affected
- 77
- Distribution
- Worldwide including USA, Austria, Canada, France, Greece, Japan, Norway, Spain & Switzerland
- Date initiated
- 2007-01-01
- Date posted
- 2007-02-15
- Date terminated
- 2007-06-22
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D (K014241) | Alsius Corp. | 2003-08-01 |