FDA Device

PASV PICC Catheter - 4.5 Fr Dual Lumen, Catalog #PIC402CK, Material Number M001PIC402CK0. Responsible firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801 USA

Hazard

Lumens may have incorrect lumen size marked on them.

What You Should Do

Remedy

Letters dated March 5, 2004 with instructions to return product to Boston Scientific.

Products

PASV PICC Catheter - 4.5 Fr Dual Lumen, Catalog #PIC402CK, Material Number M001PIC402CK0. Responsible firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Technical Park, Glens Fall
Brand
Boston Scientific Corporation
UPC
917971, 921390, 926395, 926672, 928269

Units Affected

151 units