Deflectable Tip Catheter for cardiac mapping. Mfg Part # Catalog # EU Part # D-1078-35-S 107835S SW1078-035; D-1078-63-S D5S06AL252RT 36A-07Q; D-1078-78-S 107878S N/A; D-1097-511-S 1097511S SW1097-511; D-1097-554-S D708DL002RT 36F-32Q.
- Company
- Biosense Webster, Inc.
- Recall Initiated
- August 16, 2004
- Posted
- September 2, 2004
- Terminated
- March 31, 2005
- Recall Number
- Z-1437-04
- Quantity
- 848
- Firm Location
- Irwindale, CA
Reason for Recall
Potential that product is incorrectly assembled with monel wire attached to the tip dome rather than copper wire.
Distribution
Nationwide and Japan, Europe, & Uruguay
Lot / Code Info
112 lots
Root Cause
Other
Action Taken
Sales Representative to provide letter to each of the 25 US customers explaining the action. Sales Representatives will remove any affected product from customers inventory. Certification records will be completed for each customer confirming the removal action. International affiliates to conduct similar actions.
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