VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen: CUSTOM KIT - GENESIS MEDICAL CENTER EAST, Catalog #60M120521, UPN # M00160M1205210; Firm on label: Boston Scientific Corp, NAMIC Technology Center, 10 Glens Falls Technical Park, Glens Falls, NY . DEVICE DESCRIPTION: A radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient''s skin.
Recall
- Recall Number
- Z-0407-05
- Event Number
- 30572
- Firm
- Boston Scientific Corporation
- FEI Number
- 3001451463
- Product Code
- LJS
- Status
- Terminated
- Root Cause
- Other
- Initiated
- November 22, 2004
- Posted
- January 20, 2005
- Terminated
- December 16, 2005
- Address
- 1 Boston Scientific Pl, Natick, MA, 01760-1536
Description
VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen: CUSTOM KIT - GENESIS MEDICAL CENTER EAST, Catalog #60M120521, UPN # M00160M1205210; Firm on label: Boston Scientific Corp, NAMIC Technology Center, 10 Glens Falls Technical Park, Glens Falls, NY . DEVICE DESCRIPTION: A radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient''s skin.
Catheter separation immediately distal to the nose of the suture wing.
Letters dated 11/22/2004 issued via Certified Mail. Customers instructed to return units in inventory. Patients with implanted units are to be evaluated.
75 hospitals and medical centers throughout the U.S. One foreign consignee, a hospital in New Brunswick, Canada.
179 kits