FDA Device

PASV Central Venous Catheter, 7F, Cat. # CVC702IK, Model # M0001CVC702IK. The 7Fr PASV Central Venous Catheter is a packaged configuration comprised of a silicone Central Venous Catheter with PASV Valve, Guidewire, Syringe, Needle, Tunneler, Scalpel, Sheath/Dilator, and caps. Firm on the label: Boston Scientific*** Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.

Hazard

Kits labeled to contain 0.028" guidewire contain 0.038" guidewire.

What You Should Do

Remedy

Letters dated May 25, 2004 with instructions to return product to the Quincy, MA location.

Products

PASV Central Venous Catheter, 7F, Cat. # CVC702IK, Model # M0001CVC702IK. The 7Fr PASV Central Venous Catheter is a packaged configuration comprised of a silicone Central Venous Catheter with PASV V
Brand
Boston Scientific Corporation
UPC
934445 exp. 2/28/2007; 942510 exp. 1/31/2007; 938122 exp. 3/31/2007; 935225 exp. 2/28/2007; 933703 exp 1/21/2007; 931401 exp. 12/31/2006; 929657 exp. 12/31/2006; 929435 exp. 12/31/2006.

Units Affected

290