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Terminated

Alsius Cool Line Catheter, Model CL-2295AE

FDA Recall Z-0503-2007 · Posted 2007-02-15

Recalling FirmAlsius Corporation
Recall StatusTerminated
Product CodeNCX
Date Initiated2007-01-01
Date Terminated2007-06-22
Product Quantity125

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Worldwide including USA, Austria, Canada, France, Greece, Japan, Norway, Spain & Switzerland

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K014241COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500DAlsius Corp. · 2003-08-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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