Recall Z-0502-2007
Alsius Corporation · initiated January 1, 2007
Product
Alsius Cool Line Catheter, Model CL-2295A
Codes / lots: Lot numbers: 16174
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: Other
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.
Details
- Recall number
- Z-0502-2007
- Initiated
- January 1, 2007
- Posted by FDA
- February 15, 2007
- Terminated
- June 22, 2007
- Product code
- NCX – System, Hypothermia, Intravenous, Cooling
- Quantity
- 77
- Distribution
- Worldwide including USA, Austria, Canada, France, Greece, Japan, Norway, Spain & Switzerland
- Recalling firm
- Alsius Corporation, Irvine, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0503-2007 | Alsius Cool Line Catheter, Model CL-2295AETesting by Alsius has identified that 6-10% of catheters from the three affected lots may exhibit a… | 01/01/2007Terminated |