Chilli II Cooled Ablation Cathether, Model M00490310
FDA device recall Z-0473-06 · posted 2006-02-04 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corp
- Reason for recall
- Product is mislabeled with the incorrect catheter curve description.
- Action taken
- 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
- Status
- Terminated
- Product code
- LPD
- Quantity affected
- 35 units
- Distribution
- Product was released for distribution to 14 consignees in US.
- Date initiated
- 2005-12-30
- Date posted
- 2006-02-04
- Date terminated
- 2006-08-24
- Location
- San Jose, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.