Implantable Chest Ports labeled: Titanium Single Lumen Port with PASV valve and 6.6F Silicone Catheter. Boston Scientific Cat. # PRTA66P M001PRTA66P0. Firm on label: Boston Scientific Natick, MA and Boston Scientific Corp., Glens Falls, NY.
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-0343-06
- Quantity
- 50 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
1011815, 1020902, 1021341, 1021634
Root Cause
Other
Action Taken
Boston Scientific letter dated 10/28/2005 sent via Federal Express. Customers (hospitals) instructed to remove and return product.