—#36145

Product

VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen, sold in kits, Catalog #45-454, UPN #M001454540; Firm on label: Boston Scientific, One Boston Scientific Place, Natick, MA . Manufactured at 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. Each KIT contains: catheter; cap; tape measure, 60 cm length; stylet; stylet guide/flush assembly; attachable suture wing; statlock catheter securement device; instructions for use; 21 gauge, 2.75 inch introducer needle with echogenic tip; 60 cm guidewire with floppy tip platinum tip; 10cm peelable introducer sheath with locking dilator; 10 mL syringe, scalpel; exact length measurement chart.

FDA product code: LJS — Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K021704
Affected lot / code info: 913405; 924522; 930838; 939045; 950541; 977138; 982727; 3010303254; 3010403103; 3010403104; 3011002260; 3011002261; 3011102036; 3011102037;

Why it was recalled

Catheter separation immediately distal to the nose of the suture wing.

Root cause (FDA determination)

Other

Action the firm took

Letters dated 11/22/2004 issued via Certified Mail. Customers instructed to return units in inventory. Patients with implanted units are to be evaluated.

Recalling firm

Firm: Boston Scientific Corporation
Address: 1 Boston Scientific Pl, Natick, Massachusetts 01760-1536

Distribution

Distribution pattern: 75 hospitals and medical centers throughout the U.S. One foreign consignee, a hospital in New Brunswick, Canada.

Timeline

Recall initiated: 2004-11-22
Posted by FDA: 2005-01-20
Terminated: 2005-12-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #36145. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.