Chilli II Cooled Ablation Cathether, Model M00490310
This recall has been terminated (originally issued February 4, 2006).
- Company
- Boston Scientific Corp
- Recall Initiated
- December 30, 2005
- Posted
- February 4, 2006
- Terminated
- August 24, 2006
- Recall Number
- Z-0473-06
- Quantity
- 35 units
- Firm Location
- San Jose, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Product is mislabeled with the incorrect catheter curve description.
Distribution
Product was released for distribution to 14 consignees in US.
Lot / Code Info
Batch Numbers: 804828 and 8048029
Root Cause
Other
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.
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