Silicone Central Venous Catheters with PASV Valve and Polyester Cuff - 7F. Boston Scientific Cat. #CVC702IK, M001CVC702IKO. Firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Technical Park, 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-0342-06
- Quantity
- 454 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
1009522, 1009825, 1012337, 1013926, 1017134, 1017763, 1018161, 1018456, 1022953
Root Cause
Other
Action Taken
Boston Scientific letter dated 10/28/2005 sent via Federal Express. Customers (hospitals) instructed to remove and return product.