Silicone Central Venous Catheter with PASV Valve and Polyester Cuff - 6.6F. Boston Scientific Cat. #CVC661IK M001CVC661IK0. Firm on label: Boston Scientific Corporation, NAMIC Technology Center, Glens Falls, NY 12801.
This recall has been terminated (originally issued January 6, 2006).
- Company
- Boston Scientific Corporation
- Recall Initiated
- October 28, 2005
- Posted
- January 6, 2006
- Terminated
- February 15, 2007
- Recall Number
- Z-0341-06
- Quantity
- 434 units
- Firm Location
- Natick, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Device kits contain B. Braun Locking Tearaway Introducer Systems labeled as 7Fr but may contain 8 Fr sheaths.
Distribution
DOMESTIC: Nationwide distribution. FOREIGN: Spain, France, Italy, Great Britain, Sweden, Jordan
Lot / Code Info
1009520, 1009824, 1011813, 1013925, 1018980, 1021339, 1022517, 1022952
Root Cause
Other
Action Taken
Boston Scientific letter dated 10/28/2005 sent via Federal Express. Customers (hospitals) instructed to remove and return product.