Thermocool Irrigated Catheters Celsius LABEL US Part Number# EU CATALOG # L-1189-01-S D17TCBLRT 35Q-13R PMA; L-1189-02-S
FDA device recall Z-0057-06 · posted 2005-10-15 · Terminated
Recall details
- Recalling firm
- Biosense Webster, Inc.
- Reason for recall
- Increased complaints regarding catheters with leaks and flow obstruction.
- Action taken
- Urgent letters and response forms dated August 8, 2005 directed consignees to return product.
- Root cause
- Other
- Status
- Terminated
- Product code
- LPB
- Quantity affected
- 9,679
- Distribution
- FL, iL, MA, MI, OH, OK and Belguin, Netherlands, Australia, Japan, Korea, India, Sri Lanka, New Zealand, China, Hong Kong, Singapore, Pakistan, Canada
- Date initiated
- 2005-08-08
- Date posted
- 2005-10-15
- Date terminated
- 2008-05-23
- Location
- Irwindale, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.