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Terminated

Chilli II Cooled Ablation Cathether, Model M00490310

FDA Recall Z-0473-06 · Posted 2006-02-04

Recalling FirmBoston Scientific Corp
Recall StatusTerminated
Product CodeLPD
Date Initiated2005-12-30
Date Terminated2006-08-24
Product Quantity35 units

Reason for Recall

Product is mislabeled with the incorrect catheter curve description.

Firm Action

On 12/30/05, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall.

Root Cause

Other

Distribution Pattern

Product was released for distribution to 14 consignees in US.

Official Source

View FDA Recall →

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

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